ANTI-BACTERIAL HAND GEL- ethyl alcohol gel

Anti-Bacterial Hand Gel by

Drug Labeling and Warnings

Anti-Bacterial Hand Gel by is a Otc medication manufactured, distributed, or labeled by Jean Pierre Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient: Ethyl Alcohol 62%

PURPOSE

Purpose Antiseptic

WARNINGS

Warnings: For external use only. Flammable. Keep away from fire or flame. Do not apply around eyes. Do not use in ears or mouth. When using this product, avoid contact with eyes. In case of contact, flush eyes with water.

STOP USE

Stop use or ask for a doctor if redness or irritation develops and persists for more than 72 hours.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. Children must be supervised in use of this product.

DOSAGE & ADMINISTRATION

Directions: Squeeze as needed into your palms and thoroughly spread on bottom hands. Rub into skin until dry.

INACTIVE INGREDIENT

Inactive ingredients: Water, Aloe Barbadenis Leaf, Glycerin, Propylene Glycol, Carbomer, Triethanolamine, Fragrance, FD&C Red No.4, FD&C Blue No.1, FD&C Yellow No.5

INDICATIONS & USAGE

Uses: Hand sanitizer to help decrease bacteria on the skin when water, soap & towel are not available. Recommended for repeated use

Other information

Do not store in temperature over 118 F.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ANTI-BACTERIAL HAND GEL 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70483-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
TROLAMINE (UNII: 9O3K93S3TK)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70483-001-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/25/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	05/25/2016

Labeler - Jean Pierre Inc. (138328393)