Vaccine Information: GARDASIL (Page 8 of 8)

PRINCIPAL DISPLAY PANEL — 0.5 mL Vial Carton

NDC 0006-4045-00
1 Single-dose Vial 0.5 mL

REFRIGERATE

[Human Papillomavirus
Quadrivalent
(Types 6, 11, 16, and 18)
Vaccine, Recombinant]
GARDASIL®

0.5 mL dose contains human
papillomavirus L1 protein of each
type adsorbed on amorphous
aluminum hydroxyphosphate
sulfate adjuvant as follows:
Type 6 (20 mcg), Type 11 (40 mcg),
Type 16 (40 mcg), Type 18 (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).

Contains no preservative or antibiotics.

Rx only

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

PRINCIPAL DISPLAY PANEL — 10 Single-Dose 0.5 mL Syringe Carton

NDC 0006-4109-02
10 Single-dose 0.5-mL Syringes

REFRIGERATE

[Human Papillomavirus Quadrivalent
(Types 6, 11, 16, and 18)
Vaccine, Recombinant]
GARDASIL®

Each 0.5-mL dose contains human papillomavirus L1 protein of
each type adsorbed on amorphous aluminum hydroxyphosphate
sulfate adjuvant as follows:
Type 6 (20 mcg), Type 11 (40 mcg), Type 16 (40 mcg), Type 18 (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). Contains no preservative or antibiotics.

Rx only

PRINCIPAL DISPLAY PANEL -- 10 Single-Dose 0.5 mL Syringe Carton
(click image for full-size original)
GARDASIL human papillomavirus quadrivalent (types 6, 11, 16, and 18) vaccine, recombinant injection, suspension
Product Information
Product Type VACCINE Item Code (Source) NDC:0006-4045
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 20 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 40 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 20 ug in 0.5 mL
Inactive Ingredients
Ingredient Name Strength
HISTIDINE 0.78 mg in 0.5 mL
POLYSORBATE 80 50 ug in 0.5 mL
SODIUM BORATE 35 ug in 0.5 mL
SODIUM CHLORIDE 9.56 mg 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:0006-4045-00 1 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE (0006-4045-01)
1 NDC:0006-4045-01 0.5 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (0006-4045-00)
2 NDC:0006-4045-41 10 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE (0006-4045-01)
2 NDC:0006-4045-01 0.5 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (0006-4045-41)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125126 06/08/2006
GARDASIL human papillomavirus quadrivalent (types 6, 11, 16, and 18) vaccine, recombinant injection, suspension
Product Information
Product Type VACCINE Item Code (Source) NDC:0006-4109
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 20 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 40 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 20 ug in 0.5 mL
Inactive Ingredients
Ingredient Name Strength
HISTIDINE 0.78 mg in 0.5 mL
POLYSORBATE 80 50 ug in 0.5 mL
SODIUM BORATE 35 ug in 0.5 mL
SODIUM CHLORIDE 9.56 mg 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:0006-4109-09 6 SYRINGE in 1 CARTON contains a SYRINGE (0006-4109-01)
1 NDC:0006-4109-01 0.5 mL in 1 SYRINGE This package is contained within the CARTON (0006-4109-09)
2 NDC:0006-4109-02 10 SYRINGE in 1 CARTON contains a SYRINGE (0006-4109-01)
2 NDC:0006-4109-01 0.5 mL in 1 SYRINGE This package is contained within the CARTON (0006-4109-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125126 06/08/2006
Labeler — Merck Sharp & Dohme Corp. (001317601)

Revised: 12/2020 Merck Sharp & Dohme Corp.

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