OPALINE ANTIBACTERIAL AND MOISTURIZING HAND SANITIZER- alcohol solution

OPALINE Antibacterial and Moisturizing Hand Sanitizer by

Drug Labeling and Warnings

OPALINE Antibacterial and Moisturizing Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Ganzhou Olivee Cosmetic Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Alcohol 75% w/w

Purpose

 Antiseptic

Use

Decrease bacteria on hands.

Warnings

For external use only.

Flammable.Keep product away from fire or flame.

When using this product

avoid contact with eyes; in case of contact, flush eyes with water.

Stop use and ask a doctor if

irritation or redness develops and persists.

Keep out of reach of children.

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

Small Parts. Not for children under 3 years.

Directions

Wet hands thoroughly with product and allow to dry.

Inactive ingredients

Water (Aqua), Glycerin, Fragrance (Parfum)

Packaging

INGREDIENTS AND APPEARANCE

OPALINE ANTIBACTERIAL AND MOISTURIZING HAND SANITIZER 
alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 56136-305
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	75 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 56136-305-01	100 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	04/16/2020
2	NDC: 56136-305-02	400 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	04/16/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	04/16/2020

Labeler - Ganzhou Olivee Cosmetic Co., Ltd. (543008195)

Registrant - Ganzhou Olivee Cosmetic Co., Ltd. (543008195)

Establishment
Name	Address	ID/FEI	Business Operations
Ganzhou Olivee Cosmetic Co., Ltd.		543008195	manufacture(56136-305)