ACORE LAVENDER HAND SANITIZER GIRLS- alcohol denat. gel

ACORE Lavender Hand Sanitizer by

Drug Labeling and Warnings

ACORE Lavender Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Gold Orient International Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Alcohol Denat. 62%

Purpose

Antiseptic

Use

Use for hand-washing to decrease bacteria on the skin, only when water it not available.

Warnings

For external use only. Flammable, keep away from fire and flames.

When using this product

Do not get into eyes.

If contact occurs, rinse eyes thoroughly with water.

Keep out of reach of children

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

Stop use and ask a doctor if

If irritation and redness develop.

Directions

Wet hands thoroughly with product and allow to dry without wiping.

Other information

Store at 68 to 77F (20-25C)

Do not store above 110F (43C)

You may report a serious adverse reaction to this product to Report Reaction, LLC, PO Box 22, Plainsboro, NJ 08536

Inactive ingredient

Water,

Glycerin,

Acrylates/C10-30 Alkyl Acrylate Crosspolymer,

Fragrance,

Polysorbate 20,

Sodium Hydroxide,

Red 33,

Blue 1

Label

INGREDIENTS AND APPEARANCE

ACORE LAVENDER HAND SANITIZER  GIRLS
alcohol denat. gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51522-047
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51522-047-01	1 in 1 CASE	08/03/2020
1		30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	08/03/2020

Labeler - Gold Orient International Limited (679905914)

Establishment
Name	Address	ID/FEI	Business Operations
Gold Orient International Limited		679905914	manufacture(51522-047)