Vanilla Cupcake Frosting Anti-Bacterial Scented Hand Sanitizer: Package Insert and Label Information

VANILLA CUPCAKE FROSTING ANTI-BACTERIAL SCENTED HAND SANITIZER- 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.

Drug Facts

Active ingredient

Alcohol 62%

Purpose

Antiseptic

USE

Decrease bacteria on hands

For external use only.

Flammable-  Keep produt 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

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). may contain: D&C Red No. 33 (Cl 17200), FD&C Red No. 4 (Cl 14700), FD & C Yellow No. 5 (Cl 19140), FD&C Blue No. 1 (Cl 42090).

Packaging

image description
(click image for full-size original)

VANILLA CUPCAKE FROSTING ANTI-BACTERIAL SCENTED HAND SANITIZER
alcohol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:56136-355
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 62 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER
CARBOMER COPOLYMER TYPE A
AMINOMETHYLPROPANOL
FD&C RED NO. 4
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:56136-355-01 29 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333E 06/29/2020
Labeler — Ganzhou Olivee Cosmetic Co., Ltd. (543008195)
Establishment
Name Address ID/FEI Operations
Ganzhou Olivee Cosmetic Co., Ltd. 543008195 manufacture (56136-355)

Revised: 06/2020 Ganzhou Olivee Cosmetic Co., Ltd.

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