SMARTCARE SHOPKINS- ethyl alcohol gel

SmartCare Shopkins by

Drug Labeling and Warnings

SmartCare Shopkins by is a Otc medication manufactured, distributed, or labeled by Lantern Enterprises Ltd., Shenzhen Lantern Science Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

Ethyl Alcohol 62%

PURPOSE

Purpose

Antiseptic

KEEP OUT OF REACH OF CHILDREN

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

INDICATIONS & USAGE

Uses

To help reduce bacteria and germs on the skin.

DOSAGE & ADMINISTRATION

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.

WARNINGS

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 INGREDIENT

Inactive ingredients

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SMARTCARE SHOPKINS 
ethyl alcohol gel

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

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

Inactive Ingredients
Ingredient Name	Strength
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)

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

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

Labeler - Lantern Enterprises Ltd. (004005196)

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