Vaccine Information: GARDASIL 9 (Page 8 of 8)

PRINCIPAL DISPLAY PANEL — 0.5 mL Vial Carton

NDC 0006-4119-03

10 Single-dose 0.5-mL Vials

REFRIGERATE

Human Papillomavirus 9-valent Vaccine, Recombinant

GARDASIL® 9

Suspension for intramuscular injection

Each 0.5-mL dose contains human papillomavirus L1 protein of each type adsorbed on amorphous aluminum
hydroxyphosphate sulfate adjuvant as follows:
Type 6 (30 mcg), Type 11 (40 mcg), Type 16 (60 mcg), Type 18 (40 mcg), Type 31 (20 mcg), Type 33 (20 mcg),
Type 45 (20 mcg), Type 52 (20 mcg), Type 58 (20 mcg).

Vaccine is prepared from fermentation cultures of a recombinant strain of yeast Saccharomyces cerevisiae containing the genes for the human papillomavirus L1 protein of each type (6, 11, 16, 18, 31, 33, 45, 52, 58).

Contains no preservative or antibiotics.

Rx only

PRINCIPAL DISPLAY PANEL -- 0.5 mL Vial Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 0.5 mL Syringe Carton

NDC 0006-4121-02

10 Single-dose 0.5-mL Syringes

REFRIGERATE

Human Papillomavirus 9-valent Vaccine, Recombinant

GARDASIL® 9

Suspension for intramuscular injection

Each 0.5-mL dose contains human papillomavirus L1 protein of each type
adsorbed on amorphous aluminum hydroxyphosphate sulfate adjuvant
as follows:
Type 6 (30 mcg), Type 11 (40 mcg), Type 16 (60 mcg), Type 18 (40 mcg),
Type 31 (20 mcg), Type 33 (20 mcg), Type 45 (20 mcg), Type 52 (20 mcg),
Type 58 (20 mcg).

Vaccine is prepared from fermentation cultures of a recombinant strain of yeast
Saccharomyces cerevisiae containing the genes for the human papillomavirusL1 protein of each type (6, 11, 16, 18, 31, 33, 45, 52, 58).

Contains no preservative or antibiotics.

Rx only

PRINCIPAL DISPLAY PANEL -- 0.5 mL Syringe Carton
(click image for full-size original)
GARDASIL 9 human papillomavirus 9-valent vaccine, recombinant injection, suspension
Product Information
Product Type VACCINE Item Code (Source) NDC:0006-4119
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Human Papillomavirus Type 6 L1 Capsid Protein Antigen (Human Papillomavirus Type 6 L1 Capsid Protein Antigen) Human Papillomavirus Type 6 L1 Capsid Protein Antigen 30 ug in 0.5 mL
Human Papillomavirus Type 11 L1 Capsid Protein Antigen (Human Papillomavirus Type 11 L1 Capsid Protein Antigen) Human Papillomavirus Type 11 L1 Capsid Protein Antigen 40 ug in 0.5 mL
Human Papillomavirus Type 16 L1 Capsid Protein Antigen (Human Papillomavirus Type 16 L1 Capsid Protein Antigen) Human Papillomavirus Type 16 L1 Capsid Protein Antigen 60 ug in 0.5 mL
Human Papillomavirus Type 18 L1 Capsid Protein Antigen (Human Papillomavirus Type 18 L1 Capsid Protein Antigen) Human Papillomavirus Type 18 L1 Capsid Protein Antigen 40 ug in 0.5 mL
Human Papillomavirus Type 31 L1 Capsid Protein Antigen (Human Papillomavirus Type 31 L1 Capsid Protein Antigen) Human Papillomavirus Type 31 L1 Capsid Protein Antigen 20 ug in 0.5 mL
Human Papillomavirus Type 33 L1 Capsid Protein Antigen (Human Papillomavirus Type 33 L1 Capsid Protein Antigen) Human Papillomavirus Type 33 L1 Capsid Protein Antigen 20 ug in 0.5 mL
Human Papillomavirus Type 45 L1 Capsid Protein Antigen (Human Papillomavirus Type 45 L1 Capsid Protein Antigen) Human Papillomavirus Type 45 L1 Capsid Protein Antigen 20 ug in 0.5 mL
Human Papillomavirus Type 52 L1 Capsid Protein Antigen (Human Papillomavirus Type 52 L1 Capsid Protein Antigen) Human Papillomavirus Type 52 L1 Capsid Protein Antigen 20 ug in 0.5 mL
Human Papillomavirus Type 58 L1 Capsid Protein Antigen (Human Papillomavirus Type 58 L1 Capsid Protein Antigen) Human Papillomavirus Type 58 L1 Capsid Protein Antigen 20 ug in 0.5 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE 9.56 mg in 0.5 mL
HISTIDINE 0.78 mg in 0.5 mL
POLYSORBATE 80 50 ug in 0.5 mL
SODIUM BORATE 35 ug in 0.5 mL
WATER
Product Characteristics
Color WHITE (white, cloudy) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0006-4119-03 10 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE (0006-4119-01)
1 NDC:0006-4119-01 0.5 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (0006-4119-03)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125508 12/10/2014
GARDASIL 9 human papillomavirus 9-valent vaccine, recombinant injection, suspension
Product Information
Product Type VACCINE Item Code (Source) NDC:0006-4121
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Human Papillomavirus Type 6 L1 Capsid Protein Antigen (Human Papillomavirus Type 6 L1 Capsid Protein Antigen) Human Papillomavirus Type 6 L1 Capsid Protein Antigen 30 ug in 0.5 mL
Human Papillomavirus Type 11 L1 Capsid Protein Antigen (Human Papillomavirus Type 11 L1 Capsid Protein Antigen) Human Papillomavirus Type 11 L1 Capsid Protein Antigen 40 ug in 0.5 mL
Human Papillomavirus Type 16 L1 Capsid Protein Antigen (Human Papillomavirus Type 16 L1 Capsid Protein Antigen) Human Papillomavirus Type 16 L1 Capsid Protein Antigen 60 ug in 0.5 mL
Human Papillomavirus Type 18 L1 Capsid Protein Antigen (Human Papillomavirus Type 18 L1 Capsid Protein Antigen) Human Papillomavirus Type 18 L1 Capsid Protein Antigen 40 ug in 0.5 mL
Human Papillomavirus Type 31 L1 Capsid Protein Antigen (Human Papillomavirus Type 31 L1 Capsid Protein Antigen) Human Papillomavirus Type 31 L1 Capsid Protein Antigen 20 ug in 0.5 mL
Human Papillomavirus Type 33 L1 Capsid Protein Antigen (Human Papillomavirus Type 33 L1 Capsid Protein Antigen) Human Papillomavirus Type 33 L1 Capsid Protein Antigen 20 ug in 0.5 mL
Human Papillomavirus Type 45 L1 Capsid Protein Antigen (Human Papillomavirus Type 45 L1 Capsid Protein Antigen) Human Papillomavirus Type 45 L1 Capsid Protein Antigen 20 ug in 0.5 mL
Human Papillomavirus Type 52 L1 Capsid Protein Antigen (Human Papillomavirus Type 52 L1 Capsid Protein Antigen) Human Papillomavirus Type 52 L1 Capsid Protein Antigen 20 ug in 0.5 mL
Human Papillomavirus Type 58 L1 Capsid Protein Antigen (Human Papillomavirus Type 58 L1 Capsid Protein Antigen) Human Papillomavirus Type 58 L1 Capsid Protein Antigen 20 ug in 0.5 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE 9.56 mg in 0.5 mL
HISTIDINE 0.78 mg in 0.5 mL
POLYSORBATE 80 50 ug in 0.5 mL
SODIUM BORATE 35 ug in 0.5 mL
WATER
Product Characteristics
Color WHITE (white, cloudy) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0006-4121-02 10 SYRINGE, GLASS in 1 CARTON contains a SYRINGE, GLASS (0006-4121-01)
1 NDC:0006-4121-01 0.5 mL in 1 SYRINGE, GLASS This package is contained within the CARTON (0006-4121-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125508 12/10/2014
Labeler — Merck Sharp & Dohme Corp. (001317601)

Revised: 08/2020 Merck Sharp & Dohme Corp.

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