100ML GARDENIA HAND PURIFYING- alcohol gel 
LABORATOIRES BEA

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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EUROPEAN SOAPS - 100ml Gardenia Hand purifying gel

Active Ingredient(s)

Ethyl Alcohol 70%

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

  1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  2. Glycerol (1.45% v/v).
  3. Hydrogen peroxide (0.125% v/v).
  4. Sterile distilled water or boiled cold water.

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Purpose

Antiseptic

Use

Hand Sanitizer to help reduce bacteria 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. When using the product, keep out of eyes. Do not inhale or ingest.

Do not use

on open skin wounds - around eyes - in ears and mouth

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, flush 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

Other information

Inactive ingredients


Aqua (Water), Glycerin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Parfum (Fragrance), Triethanolamine, Aloe Barbadensis Leaf Juice Powder

Package Label - Principal Display Panel

100ml Gardenia NDC 74819-0100-3

100ML GARDENIA HAND PURIFYING 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74819-0100
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
TROLAMINE (UNII: 9O3K93S3TK) 0.15 mL  in 100 mL
ALOE (UNII: V5VD430YW9) 0.0005 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 2 mL  in 100 mL
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) 0.55 mL  in 100 mL
WATER (UNII: 059QF0KO0R) 25.38941 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74819-0100-3100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/02/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E02/02/2021
Labeler - LABORATOIRES BEA (772471215)

Revised: 4/2022
Document Id: dd12a133-b421-7995-e053-2995a90ab36b
Set id: dd12aa99-8691-1b24-e053-2a95a90a227c
Version: 1
Effective Time: 20220420
 
LABORATOIRES BEA