RBX FOR MEN ANTIBACTERIAL HAND SANITIZER ALOE VERA AND TEA TREE 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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Drug Facts

Active ingredient

Alcohol 70%

Purpose

Antiseptic

Use

Decrease bacteria on hands

Warnings

For external use only.

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

Apply onto wet hands working into a lather. Rinse thorougly.

Inactive ingredients

Water (Aqua), Cocamidopropyl Betaine, Cocamidopropylamine Oxide, Hydroxethylcellulose, Fragrance (Parfum), Phenoxyethanol, Bezyl Alcohol, PEG-150 Distearate, Sodium Chloride, Glycerin, Citric Acid, Aloe Barbadensis Leaf Etract, Melaleuca alternifolia (Tea Tree) Extract, Tocopheryl Acetate. 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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RBX FOR MEN ANTIBACTERIAL HAND SANITIZER ALOE VERA AND TEA TREE SCENTED
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:56136-520
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)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
TEA TREE OIL (UNII: VIF565UC2G)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
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:56136-520-01	350 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/06/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	01/06/2021

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

Name	Address	ID/FEI	Business Operations
Establishment
Ganzhou Olivee Cosmetic Co., Ltd.		543008195	manufacture(56136-520)