La Roche Posay Antiseptic Hand Sanitizer by L'Oreal USA Products Inc / Cosmetique Active Production Drug Facts

La Roche Posay Antiseptic Hand Sanitizer by

Drug Labeling and Warnings

La Roche Posay Antiseptic Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by L'Oreal USA Products Inc, Cosmetique Active Production. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

LA ROCHE POSAY ANTISEPTIC HAND SANITIZER- alcohol gel 
L'Oreal USA Products Inc

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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Drug Facts

Active ingredient

Alcohol 71% v/v

Purpose

Antiseptic

Use

hand sanitizer to help reduce bactreria that potentially can cause disease. For use when soap and water are not available.

Warnings

For external use only. Flammable. Keep away from heat or flame.

Do not use

  • in children less than 2 months of age
  • on open skin wounds

When using this product

keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if

irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children.

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

Directions

  • place enough product on hands to cover all surfaces. Rub hands together until dry.
  • supervise chlildren under 6 years of age when using this product to avoid swallowing

Other information

● store between 15°- 30°C (59° - 86°F)
● avoid freezing and excessive heat above 40°C (104°F)

Inactive ingredients

water, glycerin, polyacryloyldimethyl taurate

Questions or comments?

1-888-LRP-LABO  1-888-577-5226

Monday - Friday (9 a.m. - 5 p.m. EST)

image of a label

image of a label

LA ROCHE POSAY ANTISEPTIC HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 49967-623
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL71 L  in 100 L
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
AMMONIUM POLYACRYLOYLDIMETHYL TAURATE (55000 MPA.S) (UNII: F01RIY4371)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 49967-623-010.195 L in 1 BOTTLE; Type 0: Not a Combination Product06/01/202006/30/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/01/202006/30/2022
Labeler - L'Oreal USA Products Inc (002136794)
Establishment
NameAddressID/FEIBusiness Operations
Cosmetique Active Production282658798manufacture(49967-623)

Revised: 6/2022