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Leaders Mediu Purifying Salt Pack

Medically reviewed on February 1, 2018

Dosage form: gel
Ingredients: Allantoin 50mg in 10mL
Labeler: SANSUNG LIFE & SCIENCE CO., LTD.
NDC Code: 69424-490

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.

ACTIVE INGREDIENT

Active Ingredient: Allantoin 0.50%

INACTIVE INGREDIENT

Inactive Ingredients: Water, Glycerin, Dipropylene Glycol, Butylene Glycol, Alcohol, Bentonite, Kaolin, Magnesium Aluminum Silicate, Polyvinyl Alcohol, Titanium Dioxide, Caprylic/Capric Triglyceride, Betaine, Sodium Chloride, Decylene Glycol, Ethylhexylglycerin, Hexylene Glycol, Boswellia serrata resin extract, Fragrance, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Xanthan gum, Ferric Ammonium Ferrocyanide, Isohexadecane, Polysorbate 80, Rubus coreanus fruit extract, Cnidium officinale root extract, Snail secretion filtrate, Disodium EDTA, CI 19140, CI 42090, Totarol

PURPOSE

Purpose: Skin Protectant

WARNINGS

Warnings: For external use only. Avoid contact with eyes. Not for human consumption. Discontinue use if irritation occurs. If irritation persists, consult a physician.

Use immediately after opening. Store in cool and dry place. Keep out of reach of children.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

Directions

Directions: After cleansing face, apply a thin layer of the Wash-Off Pack on the face, leaving out the area around eyes and mouth. Leave on for 5-10 minutes then wash off with tepid water. *Suggested use is 2-3 times a week.

Directions

Directions: After cleansing face, apply a thin layer of the Wash-Off Pack on the face, leaving out the area around eyes and mouth. Leave on for 5-10 minutes then wash off with tepid water. *Suggested use is 2-3 times a week.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LEADERS MEDIU PURIFYING SALT PACK 
allantoin gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69424-490
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Allantoin (ALLANTOIN) Allantoin50 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
Water 
Glycerin 
Packaging
#Item CodePackage Description
1NDC:69424-490-0110 mL in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34712/01/2015
Labeler - SANSUNG LIFE & SCIENCE CO., LTD. (689524929)
Registrant - SANSUNG LIFE & SCIENCE CO., LTD. (689524929)
Establishment
NameAddressID/FEIOperations
SANSUNG LIFE & SCIENCE CO., LTD.689524929manufacture(69424-490)

 
SANSUNG LIFE & SCIENCE CO., LTD.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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