BACTIVE HAND SANITIZER- ethyl alcohol gel

Bactive Hand Sanitizer by

Drug Labeling and Warnings

Bactive Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Zuru LLC, Opal Cosmetics (Huizhou) Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Ethyl Alcohol 70%.

Purpose

Antiseptic

Use

• For handwashing to decrease bacteria on the skin
• Recommended for repeat use

Warnings

For external use only - hands. Flammable. Keep away from heat or flame.

WHEN USING

When using this product

■ keep out of eyes. In case of contact with eyes, flush thoroughly with water.

■ avoid contact with broken skin.

■ do not inhale or ingest.

STOP USE

Stop use and ask a doctor

• If irritation and redness develop.
• If condition persists for more than 72 hours consult a doctor.

KEEP OUT OF REACH OF CHILDREN

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
• for children under 6, use only under adult supervision
• not recommended for infants

Other information

• Store between 15-30C (59-86F)
• use within 12 months of opening
• may discolour some fabrics
• harmful to wood finishes and plastics

Inactive ingredients

acrylates/c10-30 alkyl acrylate crosspolymer, aloe barbedensis leaf extract, aminomethyl propanol, fragrance, glycerin, maltodextrin, water

Package Label - Principal Display Panel

50 mL

500 mL

2L

INGREDIENTS AND APPEARANCE

BACTIVE HAND SANITIZER 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76658-115
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
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
GLYCERIN (UNII: PDC6A3C0OX)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76658-115-01	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/17/2020
2	NDC: 76658-115-09	2000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/17/2020
3	NDC: 76658-115-02	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/17/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/17/2020

Labeler - Zuru LLC (080435986)

Establishment
Name	Address	ID/FEI	Business Operations
Opal Cosmetics (Huizhou) Limited		528178475	manufacture(76658-115) , label(76658-115)