Checker Antibacterial Hand Gel Antiseptic Alcohol 70%

Checker Antibacterial Hand Antiseptic Alcohol 70 by

Drug Labeling and Warnings

Checker Antibacterial Hand Antiseptic Alcohol 70 by is a Otc medication manufactured, distributed, or labeled by Lubricantes de América, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

CHECKER ANTIBACTERIAL HAND ANTISEPTIC ALCOHOL 70- alcohol gel 
Lubricantes de América, 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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Checker Antibacterial Hand Gel Antiseptic Alcohol 70%

Drug Facts

Active Ingredients

Alcohol 70% v/v

Porpose

Antiseptic

Use

as instant hand antiseptic. This Product DOES NOT replace hand washing with soap and water.

Warnings

Flammable, keep away from fire or flame. For external use only. Read label before use.

When using this product.

keep out of eyes. If contact with eyes occurs. rinse promptly with water.

Stop use and ask a doctor

if significant irritation or sensitization develops.

Keep out of reach of children.

Directions.

Apply to clean, dry hands. Wet hands thoroughly with product and allow to dry.

Other information

*Kills 99.99 % of E.coli, Salmonella spp. and P. aeruginosa.

Inactive Ingredients

Water, carbomer, aminomethyl propanol, glycerin.

Package Labeling:

CHECKER ANTIBACTERIAL HAND ANTISEPTIC ALCOHOL 70 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79338-004
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)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79338-004-01	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/31/2020	11/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	07/31/2020	11/01/2021

Labeler - Lubricantes de América, S.A. de C.V. (812373108)

Revised: 11/2021

Document Id: d00ce71d-264c-6e56-e053-2995a90a9da9

34390-5

Set id: b6be1503-0360-cdff-e053-2995a90a8192

Version: 2

Effective Time: 20211105