BIOTOP PROFESSIONAL ANTISEPTIC HAND SANITIZER

BIOTOP PROFESSIONAL ANTISEPTIC HAND SANITIZER by

Drug Labeling and Warnings

BIOTOP PROFESSIONAL ANTISEPTIC HAND SANITIZER by is a Otc medication manufactured, distributed, or labeled by G.v. Cosmetics Ltd, G.V. COSMETICS LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

BIOTOP PROFESSIONAL ANTISEPTIC HAND SANITIZER- benzalkonium chloride liquid 
G.v. Cosmetics Ltd

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BIOTOP PROFESSIONAL ANTISEPTIC HAND SANITIZER

Drug Facts

Active ingredient

Benzalkonium chloride 0.1%

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 alpha-isomethyl ionone, benzethonium chloride, benzyl salicylate, citronellol, cocamidopropyl betaine, ethyl alcohol, FD&C Blue no. 1, fragrance, hexyl cinnamal, hydroxycitronellal, limonene, linalool, propylene glycol, sodium lauryl sulfoacetate, tocopheryl acetate, water

Without soap or water
No rinse - no fuss

No sticky residue

HYGIENIC

BIOTOP®

PROFESSIONAL

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

Packaging

BIOTOP PROFESSIONAL ANTISEPTIC HAND SANITIZER 
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79096-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
BENZETHONIUM CHLORIDE (UNII: PH41D05744)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
ALCOHOL (UNII: 3K9958V90M)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM LAURYL SULFOACETATE (UNII: D0Y70F2B9J)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79096-002-03	30 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	10/13/2020	12/01/2022
2	NDC: 79096-002-05	50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	10/13/2020	12/01/2022
3	NDC: 79096-002-70	70 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	10/13/2020	12/01/2022
4	NDC: 79096-002-80	80 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	10/13/2020	12/01/2022
5	NDC: 79096-002-10	100 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	10/13/2020	12/01/2022
6	NDC: 79096-002-12	120 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	10/13/2020	12/01/2022
7	NDC: 79096-002-15	150 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	10/13/2020	12/01/2022
8	NDC: 79096-002-18	180 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	10/13/2020	12/01/2022
9	NDC: 79096-002-20	200 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	10/13/2020	12/01/2022
10	NDC: 79096-002-25	250 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	10/13/2020	12/01/2022
11	NDC: 79096-002-30	300 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	10/13/2020	12/01/2022
12	NDC: 79096-002-50	500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	10/13/2020	12/01/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	10/13/2020	12/01/2022

Labeler - G.v. Cosmetics Ltd (649551330)

Establishment
Name	Address	ID/FEI	Business Operations
G.V. COSMETICS LTD		649551330	manufacture(79096-002)

Revised: 12/2023

Document Id: a3f35a97-1ed0-48f1-abf2-41ad13685143

34390-5

Set id: 3ad183ab-6b1b-4deb-82d5-d1f63ca1f1a8

Version: 2

Effective Time: 20231205