59ML CITRUS DELIGHT HAND SANITIZER- 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.

----------

MISTRAL - 59ml Citrus Delight Hand sanitizer

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.

Active Ingredient(s)

Ethyl Alcohol 74%

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

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, 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

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

59ml NDC: 74819-0011-2

59ML CITRUS DELIGHT HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74819-0011
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL74 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) 5 mL  in 100 mL
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) 0.5 mL  in 100 mL
WATER (UNII: 059QF0KO0R) 19.9495 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74819-0011-259 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/22/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E02/22/2021
Labeler - LABORATOIRES BEA (772471215)

Revised: 2/2021
Document Id: bb870888-dbc2-232a-e053-2995a90a4c95
Set id: bb870888-dbc3-232a-e053-2995a90a4c95
Version: 1
Effective Time: 20210217
 
LABORATOIRES BEA