BODY GLOVE FOR MEN ANTIBACTERIAL HAND SANITIZER TEA TREE AND VITAMIN E SCENTED- alcohol liquid
Ganzhou Olivee Cosmetic Co., Ltd.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Hand Wash

Drug Facts

Active ingredient

Alcohol 70%

Purpose

Antibacterial

Use

Decreases bacteria on hands

Warnings

For external use only.

Flammbale, 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 and redness develops and persists.

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.

Inactive ingredients

Water (Aqua), Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl Propanol, Fragrance (Parfum), Tocopheryl Acetate, Butyrospermum Parkii (Shea Butter) Extract. May contain: FD&C Red No. 4 (C.I. 14700), FD&C Yellow No. 5 (C.I. 19140), D&C Red No. 33 (Cl 17200), FD&C Blue No. 1 (Cl 42090).

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BODY GLOVE FOR MEN ANTIBACTERIAL HAND SANITIZER TEA TREE AND VITAMIN E SCENTED
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:56136-497
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)
AMINOMETHYL PROPANEDIOL (UNII: CZ7BU4QZJZ)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
SHEA BUTTER (UNII: K49155WL9Y)
FD&C RED NO. 3 (UNII: PN2ZH5LOQY)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:56136-497-01	350 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/13/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	11/13/2020

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

Name	Address	ID/FEI	Business Operations
Establishment
Ganzhou Olivee Cosmetic Co., Ltd.		543008195	manufacture(56136-497)