SMARTCARE SHOPKINS- ethyl alcohol gel
Lantern Enterprises 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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Active Ingredient

Ethyl Alcohol 62%

Purpose

Antiseptic

Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center right away.

Uses

To help reduce bacteria and germs on the skin.

Directions

Place enough product in palm to cove rhands and rub hands briskly together until dry.
Children under 6, use only under adult supervision.
Not recommended for infants.

Warning

Flammable. Keep away from fire or flame. For external use only.

Stop use and ask a doctor if irritation or redness develops and persists.

Inactive ingredients

aloe barbadensis gel, carbomer, fragrance, glycerin, isopropyl myristate, propylene glycol, tocopheryl acetate, triethanolamine, water

label2

SMARTCARE SHOPKINS
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50154-010
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:50154-010-01	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/27/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	10/27/2017

Labeler - Lantern Enterprises Ltd. (004005196)

Name	Address	ID/FEI	Business Operations
Establishment
Shenzhen Lantern Science Co., Ltd.		421222423	manufacture(50154-010)