PRIDE PRODUCTS - ANTI-BACTERIAL HAND GEL - 62% ETHYL ALCOHOL (58037-103), DELIST

ANTI-BACTERIAL HAND by

Drug Labeling and Warnings

ANTI-BACTERIAL HAND by is a Otc medication manufactured, distributed, or labeled by Pride Products Corp.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ANTI-BACTERIAL HAND- ethyl alcohol gel 
Pride Products Corp.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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PRIDE PRODUCTS - ANTI-BACTERIAL HAND GEL - 62% ETHYL ALCOHOL (58037-103), DELIST

ACTIVE INGREDIENT

ETHYL ALCOHOL 62%

PURPOSE

ANTIMICROBIAL

USES

KILLS 99.9% OF GERMS ON SKIN

WARNINGS

FOR EXTERNAL USE ONLY. FLAMMABLE.

KEEP AWAY FROM HEAT AND FLAME.

WHEN USING THIS PRODUCT: AVOID CONTACT WITH FACE, EYES, AND BROKEN SKIN. IN CASE OF EYE CONTACT, FLUSH WITH PLENTY OF WATER AND SEEK MEDICAL ADVICE.

STOP USE AND ASK A DOCTOR IF IRRITATION OR REDNESS DEVELOPS.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center.

DIRECTIONS

WET HANDS THOROUGHLY WITH PRODUCT AND RUB INTO SKIN UNTIL DRY. CHILDREN UNDER 6 YEARS OF AGE SHOULD BE SUPERVISED BY AN ADULT WHEN USING THIS PRODUCT.

INACTIVE INGREDIENTS

WATER, GLYCERIN, CARBOMER, VE, FLAVOR

ANTI-BACTERIAL HAND 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58037-103
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)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58037-103-08	236 mL in 1 TUBE; Type 0: Not a Combination Product	09/22/2020	12/31/2021
2	NDC: 58037-103-02	60 mL in 1 TUBE; Type 0: Not a Combination Product	09/22/2020	12/31/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/22/2020	12/31/2021

Labeler - Pride Products Corp. (109020099)

Revised: 1/2022

Document Id: d57be6ce-79d6-b625-e053-2a95a90a93a7

34390-5

Set id: 0d0568c7-27fe-42eb-b6b5-0b559e5a7eb7

Version: 2

Effective Time: 20220113