INSTANT HAND SANITIZER gel

INSTANT HAND SANITIZER by

Drug Labeling and Warnings

INSTANT HAND SANITIZER by is a Otc medication manufactured, distributed, or labeled by Jean Pierre Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Ethyl Alcohol 60%

Purpose

Antiseptic

Use

Helps reduce bacteria on skin. For use when soap and water are not available.

Warnings

For external use only. Flammable. Keep away from fire or flame.

Do not use

do not use in or near tile eyes

WHEN USING

When using this product do not use in or near tile eyes. In case of contact, rinse eyes thoroughly with water. Do not use on open skin wounds. Stop use and ask a doctor if irritation or rash appears and lasts. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

STOP USE

Stop use and ask a doctor if irritation or rash appears and lasts.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

Directions

Apply enough product on hands to cover all surfaces. Rub hands together until dry.
Supervise children under 6 years of age when using this product.

Other information

Do not store in temperature over 118°F.

INACTIVE INGREDIENT

Water, Carbomer, Triethanolamine, Fragrance, Glycerine, Tocopherol (Vitamin E), Aloe Barbadensis Leaf Juice

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

INSTANT HAND SANITIZER 
instant hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70483-008
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	60 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PODOPHYLLUM RESIN (UNII: 16902YVY2B)
TOCOPHEROL (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70483-008-01	52 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
2	NDC: 70483-008-02	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/30/2020

Labeler - Jean Pierre Inc. (138328393)

Establishment
Name	Address	ID/FEI	Business Operations
Jean Pierre Inc.		138328393	manufacture(70483-008)