Hand Sanitizing Gel Frota

Hand Sanitizing Gel Frota by

Drug Labeling and Warnings

Hand Sanitizing Gel Frota by is a Otc medication manufactured, distributed, or labeled by Integradora de Espectáculos de Guadalajara, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HAND SANITIZING GEL FROTA- alcohol gel 
Integradora de Espectáculos de Guadalajara, S.A. de C.V.

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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Hand Sanitizing Gel Frota

Drug Facts

Active ingredient

Ethyl alcohol 70% v/v

purspose

Antimicrobial

Uses:

* Hand sanitizer to help redice bacterial on the skin that could of cause* recomendended for repeated use.

Warnings

Flammable, keep away from fire of flame.

For external use only.

When using this product

do not use in or near the eyes. In case of contact, rinse eyes throughly with wáter.

Stop uses and ask a doctor

if irritation or rash appears and lasis.

Keep out of reach of children.

I swallowed, get medical help or contact a posion control center right away.

Directions

Place enough product in your palm to throughly over your hands * Rub hands together briskly until dry*children under 6 years of age should be supervised when using this product.

Inactive ingredients

Water, glycerin, carbomer, triethanolamine y fragance..

Package Labeling:

HAND SANITIZING GEL FROTA 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81356-000
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.7 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81356-000-01	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/30/2020	06/06/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	12/30/2020	06/06/2022

Labeler - Integradora de Espectáculos de Guadalajara, S.A. de C.V. (816610638)

Revised: 10/2022

Document Id: ec0847af-088a-3dfc-e053-2995a90a6bb7

34390-5

Set id: b8670880-5585-8722-e053-2a95a90aad48

Version: 2

Effective Time: 20221027

 

Integradora de Es