Antiseptic Hand Sanitizer Gel

Antiseptic Hand Sanitizer Gel by

Drug Labeling and Warnings

Antiseptic Hand Sanitizer Gel by is a Otc medication manufactured, distributed, or labeled by Recubrimientos Ecologicos y Reciclados, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ANTISEPTIC HAND SANITIZER GEL- alcohol gel 
Recubrimientos Ecologicos y Reciclados, 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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Antiseptic Hand Sanitizer Gel

Drug Facts

Active ingredient

Ethyl alcohol 70%

Purpose

Antiseptic

Use

For hand washing to decrease bacteria on the skin

Warnings

For external use only

Flammable, keep away from fire or flame.

Do not use 

in the eyes

Stop use and ask a doctor if

• irritation and redness develop
• condition persists for more than 72 hours

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

wet hands thoroughly with product and allow to dry without wiping

Other information

Keep tightly closed, in the original container.

Inactive ingredients

Water, carbomer, glycerin, triethanolamine.

Questions or comments

(210) 254-5354

Package Labeling:

ANTISEPTIC HAND SANITIZER GEL 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78648-000
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)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
GLYCERIN (UNII: PDC6A3C0OX)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78648-000-01	4000 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/30/2020	10/31/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	09/30/2020	10/31/2022

Labeler - Recubrimientos Ecologicos y Reciclados, S.A. de C.V. (812819002)

Establishment
Name	Address	ID/FEI	Business Operations
Recubrimientos Ecologicos y Reciclados, S.A. de C.V.		812819002	manufacture(78648-000)

Revised: 11/2022

Document Id: ed21864f-7e9c-1977-e053-2995a90a0f22

34390-5

Set id: ae571e70-cf9b-c937-e053-2995a90aceb7

Version: 2

Effective Time: 20221110

 

Recubrimient