You Are My Sunshine Antibacterial Hand Wash Watermelon Scented: Package Insert and Label Information

YOU ARE MY SUNSHINE ANTIBACTERIAL HAND WASH WATERMELON SCENTED- benzalkonium chloride 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.

Drug Facts

Active ingredient

Benzalkonium Chloride 0.1500%

Purpose

Antibacterial

USE

Helps eliminate 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 or redness develops and persists.

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, Decyl Glucoside, Cocamidopropylamine Oxide Peg-80 Glyceryl Cocoate, Fragrance (Parfum), Phenoxyethanol, Benzyl Alcohol, Peg-15 Distearate, Glycol Distearate, Sodium Chloride, Citric Acid. May contain: FD &C Red No. 4 (C.I. 14700), FD&C Yellow No. 5 (C.I. 19140), FD&C Blue No. 1 (C.I. 42090), FD&C Red No.33 (C.I. 17200).

Hand wash

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YOU ARE MY SUNSHINE ANTIBACTERIAL HAND WASH WATERMELON SCENTED
benzalkonium chloride liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:56136-513
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE 1.5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
COCAMIDOPROPYL BETAINE
COCAMIDOPROPYLAMINE OXIDE
BENZYL ALCOHOL
GLYCERIN
ACETYLTRIETHYL CITRATE
ASCORBIC ACID
PHENOXYETHANOL
GLYCOL DISTEARATE
SODIUM CHLORIDE
PEG-80 GLYCERYL COCOATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:56136-513-01 350 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 11/27/2020
Labeler — Ganzhou Olivee Cosmetic Co., Ltd. (543008195)
Establishment
Name Address ID/FEI Operations
Ganzhou Olivee Cosmetic Co., Ltd. 543008195 manufacture (56136-513)

Revised: 11/2020 Ganzhou Olivee Cosmetic Co., Ltd.

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