BIOFRESH HAND SANITIZER- alcohol gel

BIOFRESH HAND SANITIZER by

Drug Labeling and Warnings

BIOFRESH HAND SANITIZER by is a Otc medication manufactured, distributed, or labeled by HINDUSTAN HERBAL COSMETICS. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient :

Alcohol IP (Denatured) eq. to absolute alcohol 70% v/v

Purpose

Antimicrobial

INDICATIONS & USAGE

​Uses: For handwashing to decrease bacteria on the skin recommended for repeated use

Warnings

For external use only.

Flammable, Keep away from heat or flame.

Do not use in the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation and redness develop and persist for more than 72 hours.

Keep out of reach of children. If swallowed, get medical help

DOSAGE & ADMINISTRATION

​Directions wet hands thoroughly with product briskly rub hands together until dry supervise children under 6 years in the use of this product

INACTIVE INGREDIENT

Ingredients: Alcohol IP (Denatured) 70% v/v, Glycerin, Propylene Glycol, Tea Tree Extract, Aloevera Extract, Triethanolamine, Color, Purified Water

SPL UNCLASSIFIED SECTION

Kills 99.99% of Germs

Protects Hands

Refreshing & Protection Gel

With Moisturizer Neem Extract & Vitamins E & A

Manufactured by :

HINDUSTAN HERBAL COSMETICS

Visit us : www.biofreshherbals.com

Made In India​

Packaging

INGREDIENTS AND APPEARANCE

BIOFRESH HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77104-999
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77104-999-04	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/10/2020
2	NDC: 77104-999-03	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/10/2020
3	NDC: 77104-999-02	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/10/2020
4	NDC: 77104-999-01	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/10/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/10/2020

Labeler - HINDUSTAN HERBAL COSMETICS (860308144)

Establishment
Name	Address	ID/FEI	Business Operations
HINDUSTAN HERBAL COSMETICS		860308144	manufacture(77104-999)