OPLUS ANTISEPTIC INSTANT HAND SANITIZER- alcohol gel

OPLUS Antiseptic Instant Hand Sanitizer by

Drug Labeling and Warnings

OPLUS Antiseptic Instant Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by TDC USA Inc, Opal Cosmetics (Huizhou) Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Ethyl alcohol 75%

Purpose

Antiseptic

Use

For hand washing to decrease bacteria on the skin

Warnings

For external use only

Flammable, keep away from fire or flame.

Do not use

in the eyes

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

Other information

• do not store above 105°F (41°C)
• may discolor certain fabrics
• harmful to wood finishes and plastics

Inactive ingredients

Water, glycerin, acrylates/C10-30 alkyl acrylate crosspolymer, fragrance, aminomethyl propanol, Aloe vera leaf extract, denatonium benzoate, t-butyl alcohol, maltodextrin

Package Labeling

INGREDIENTS AND APPEARANCE

OPLUS ANTISEPTIC INSTANT HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79204-000
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.75 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)
MALTODEXTRIN (UNII: 7CVR7L4A2D)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79204-000-00	95 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/31/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	07/31/2020

Labeler - TDC USA Inc (054204290)

Establishment
Name	Address	ID/FEI	Business Operations
Opal Cosmetics (Huizhou) Limited		528178475	manufacture(79204-000)