RBX HAND SANITIZER OCEAN SCENTED ALLOE VERA AND VITAMIN E- alcohol gel
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 SANITIZER

Drug Facts

Active ingredient

Alcohol 65%

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.

Directions

Wet hands thoroughly with product and allow to dry.

Inactive ingredients

Water (Aqua), ACRYLATES/C10-30 ALKYL ACRYLATE CROSSCOPOLYMER, AMINOMETHYL PROPANOL, Fragrance (Parfum), Rose Flower Oil, Cannabis Sativa Seed Oil, Argania Spinosa Kernel Oil, May Contain: D&C Red No. 33 (Cl17200), FD&C Red No.4 (Cl14700), FD&C Yellow No. 5 (Cl19140), FD&C Blue No. 1 (Cl 42090).

Warning - Choking Hazard

Small parts. Not for children under 3 years.

Packaging

image description

RBX HAND SANITIZER OCEAN SCENTED ALLOE VERA AND VITAMIN E
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:56136-463
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	65 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)

Ingredient Kind	Ingredient Name	Quantity
Other Ingredients
May contain	D&C RED NO. 33 (UNII: 9DBA0SBB0L)
May contain	FD&C RED NO. 4 (UNII: X3W0AM1JLX)
May contain	FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
May contain	FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:56136-463-01	45 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/03/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	11/03/2020

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

Name	Address	ID/FEI	Business Operations
Establishment
Ganzhou Olivee Cosmetic Co., Ltd.		543008195	manufacture(56136-463)