OTC Medication Information: CELLSKIN THE CLEAN HAND SANITIZER

CELLSKIN THE CLEAN HAND SANITIZER- alcohol gel
GTG Wellness Co., Ltd.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

ACTIVE INGREDIENT

ALCOHOL 62%

INACTIVE INGREDIENTS

Water, Glycerin, Carbomer, Propylene Glycol, Triethanolamine, Menthol, Camellia Sinensis Leaf Extract, Citrus Paradisi (Grapefruit) Fruit Extract,
Dimethicone, Tocopheryl Acetate, CI 42053

PURPOSE

SANITIZER

WARNINGS

For external use only. Flammable. Keep away from heat or flame
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Do not use
• in children less than 2 months of age
• on open skin wounds
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When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
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Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

KEEP OUT OF REACH OF CHILDREN

If swallowed, get medical help or contact a Poison Control Center right away.

Uses

Hand sanitizer to help reduce bacteria that potentially can cause disease.

Directions

• Place enough product on hands to cover all surfaces. Rub hands together until dry.
• Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

• Store between 15-30℃ (59-86F)
• Avoid freezing and excessive heat above 40℃ (104F)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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(click image for full-size original)

CELLSKIN THE CLEAN HAND SANITIZER
alcohol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:71080-0018
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 0.93 g in 1.5 mL
Inactive Ingredients
Ingredient Name Strength
Water
Glycerin
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE
Propylene Glycol
TROLAMINE
Menthol
GREEN TEA LEAF
GRAPEFRUIT
Dimethicone
.ALPHA.-TOCOPHEROL ACETATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71080-0018-2 20 POUCH in 1 CARTON contains a POUCH (71080-0018-1)
1 NDC:71080-0018-1 1.5 mL in 1 POUCH This package is contained within the CARTON (71080-0018-2)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 05/01/2020
Labeler — GTG Wellness Co., Ltd. (689458057)
Registrant — GTG Wellness Co., Ltd. (689458057)
Establishment
Name Address ID/FEI Operations
Natural Korea Co., Ltd. 688729438 manufacture (71080-0018)

Revised: 06/2020 GTG Wellness Co., Ltd.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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