BIOTIPO PHARMA MEDICAL BIOGEL- alcohol gel
Unibeleza Industria e Comercio de Cosmeticos Ltda

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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Biotipo Pharma Medical Biogel

Drug Facts

Active Ingredient

Ethyl Alcohol 70% v/v

Purpose

Antiseptic

Uses

Hand Sanitizer to Help reduce Bacteria on the skin. The Biotipo Pharma Medical BioGel Alcohol Gel 70% Antiseptic Aloe Vera Hand Sanitizer is used as a complement to routine hand cleaning. Without rinising, it leaves no fragrance residue and eliminates 99.99% of germs in the region.

WARNINGS:

Flammable Product. Keep away from source of heat, fire or flame. FLammable product can cause burns.

For External Use Only.

When using this product

avoid direct contact with eyes and mucous membranes. If contact occurs. Rinse with water. Do not ingest the product.

Stop use and ask a doctor if

irritation or redness develops and lasts

Keep out of reach of children

Keep out of reach of children, in case of accidental ingestion, get medical help or contact a Poison control center or Health Services immediately.

DIRECTIONS:

-Apply a small amount of Biotipo Pharma Medical BioGel Alcohol Gel 70% Antiseptic Aloe Vera on the palm of the hand and rub until dry. No water or towel is required.

-Children under 6 years should be supervised when using this product.

- DO NOT SWALLON - containes denaturant. THe product contains VEGETABLE GLYCERINE as a denaturant

Inactive Ingredients

Aqua(Water), Vegetable Glycerin, Carbomer, Triethanolamine, Parfum, Benzyl Salicylate, Linalool, Limonene, Hidroxycitronellal, Coumarin, Tocopheryl Acetate, Aloe Babarbadensis Leaf Juice, Cinnamomun Camphora Leaf oil.

Other Information.

Store at a temperature below 110°F (43%).

May discolor certain fabrics of surfaces.

Keep the product in its original packing.

Questions or Comments: 1 617-710-8020

Package Labeling 50ml

BIOTIPO 050ML

Package Labeling 100ml

BIOTIPO 100ML

Package Labeling 200ml

BIOTIPO200ML

Package labeling 250ml

BIOTIPO 250ML

Package Lableing 500ml

BIOTIPO 500ML

BIOTIPO PHARMA MEDICAL BIOGEL
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:77457-001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.7 mL in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
TROLAMINE (UNII: 9O3K93S3TK)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
COUMARIN (UNII: A4VZ22K1WT)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CAMPHOR LEAF OIL (UNII: 51D0RGY52V)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:77457-001-05	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/08/2020	08/31/2023
2	NDC:77457-001-04	250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/08/2020	08/31/2023
3	NDC:77457-001-02	100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/08/2020	08/31/2023
4	NDC:77457-001-01	50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/08/2020	08/31/2023
5	NDC:77457-001-03	200 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/08/2020	08/31/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	07/08/2020	08/31/2023

Labeler - Unibeleza Industria e Comercio de Cosmeticos Ltda (679072947)

Revised: 5/2021

Document Id: c2b1f6db-b6d7-36d4-e053-2995a90a21cf

Set id: a97a7bca-ead6-141f-e053-2a95a90a1fe2

Version: 6

Effective Time: 20210519

Unibeleza Industria e Comercio de Cosmeticos Ltda