BIOTOP PROFESSIONAL ANTISEPTIC HAND SANITIZER- alcohol gel
G.V. COSMETICS LTD

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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BIOTOP PROFESSIONAL HYGEINIC ANTISEPTIC HAND SANITIZER

Drug Facts

Active ingredient

Alcohol 70% v/v

Purpose

Antiseptic

Uses

hand sanitizer to decrease bacteria on the skin
recommended for repeated use
for use when soap and water are not available

Warnings

Flammable, keep away from fire/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 get into eyes. In case of contact, rinse eyes thoroughly with water
Stop use and ask a doctor if

irritation and redness develop
condition persists for more than 72 hours

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

wet hands thoroughly with product and allow to dry without wiping
supervise children under 6 years of age when using this product to avoid swallowing

Other information

store between 15-30°C (59-86°F)
avoid freezing and excessive heat above 40°C (104°F)

Inactive ingredients

acrylates/C10-30 alkyl acrylate crosspolymer, aloe vera (Aloe barbadensis) leaf water, alpha-isomethyl ionone, benzalkonium chloride, benzyl alcohol, butylphenyl methylpropional, FD&C Blue No. 1, fragrance, glycerin, potassium sorbate, sodium benzoate, triethanolamine, water

Rinse- free | with Aloe Vera

Manufactured by: G.V. Cosmetics Ltd.
34 Ben-Zion Galis St. Segula,Petach Tikva, Israel, 4927934

Made In Israel

You may also report serious side effects to this address.
BIOTOP PROFESSIONAL USA, INC.
2723 W Touhy Ave, Chicago, IL 60645

www.biotopworld.com | Info@biotopworld.com

Lot No:
Expiry:

Packaging

image description

BIOTOP PROFESSIONAL ANTISEPTIC HAND SANITIZER
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:79096-001
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
BENZYL ALCOHOL (UNII: LKG8494WBH)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GLYCERIN (UNII: PDC6A3C0OX)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:79096-001-60	60 mL in 1 TUBE; Type 0: Not a Combination Product	07/16/2020
2	NDC:79096-001-10	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/16/2020
3	NDC:79096-001-33	330 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/16/2020
4	NDC:79096-001-50	500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/16/2020
5	NDC:79096-001-51	500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/16/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	07/16/2020

Labeler - G.V. COSMETICS LTD (649551330)

Name	Address	ID/FEI	Business Operations
Establishment
G.V. COSMETICS LTD		649551330	manufacture(79096-001)

Revised: 7/2020

Document Id: 35f3d6c1-b328-4939-a935-943662354d8e

Set id: 019458e2-6231-44eb-af39-a06f0367bd7f

Version: 1

Effective Time: 20200716

G.V. COSMETICS LTD