Hand Sanitizer Gel by Albess for Cosmetics

Hand Sanitizer Gel by

Drug Labeling and Warnings

Hand Sanitizer Gel by is a Other medication manufactured, distributed, or labeled by Albess for Cosmetics. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HAND SANITIZER GEL 85 ML- alcohol gel 
Albess for Cosmetics

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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) (76%, 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. Carbomer 940 (0.5% v/v).
4. triethanolamine (0.18%v/v)
5. 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)

Alcohol 76% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria on skin

Warnings

Flammable. Keep away from fire or flame

For external use only.

Do not use

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

When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.
Discontinue if skin irritation occurs. if condition persist consult a doctor.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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

• Squeeze a small amount of Natural Glow Hand Sanitizer in your palm then briskly rub hands together until dry.

Other information

• Store between bellow 30C
• May disolor some fabrics or surfaces

Inactive ingredients

water, glycerin, Crbomer, Triethanolamine

Package Label - Principal Display Panel

85 mL

HAND SANITIZER GEL  85 ML
alcohol gel

Product Information
Product Type	COSMETIC	Item Code (Source)	80011-102
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	64.6 mL  in 85 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)	1.16 mL  in 85 mL
CARBOMER 940 (UNII: 4Q93RCW27E)	0.425 g  in 85 mL
TROLAMINE (UNII: 9O3K93S3TK)	0.153 g  in 85 mL
WATER (UNII: 059QF0KO0R)	18.862 mL  in 85 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	80011-102-01	85 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	08/13/2020

Labeler - Albess for Cosmetics (562370370)

Establishment
Name	Address	ID/FEI	Business Operations
Albess for Cosmetics		562370370	manufacture(80011-102)

Revised: 8/2020

Document Id: 6ee9e404-d853-4824-bd6d-51e0f0ac9241

58474-8

Set id: f2cc2bc1-9574-4fd5-b813-c1aa85426c9c

Version: 4

Effective Time: 20200813