Label: SEAWEED CLEANSING- mineral oil liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 60899-050-01 - Packager: AMAROS CO., LTD.
- Category: HUMAN OTC DRUG LABEL
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 Label Information
Updated April 11, 2019
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- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
Inactive Ingredients: Water, Butylene Glycol, Polysorbate60, Cetyl Alcohol, Glycerin, Glyceryl Stearate SE, Sorbitan Sesquioleate, Dimethicone, Caprylyl Glycol / Caprylhydroxamic Acid, Carbomer, Triethanolamine, Allantoin, Xanthan Gum, Simmondsia Chinensis(Jojoba) Seed Oil, Sesamum Indicum (Sesame) Seed Oil, Triticum Vulgare (Wheat) Germ Oil, Algae Extract, Carica Papaya (Papaya) Leaf Extract, Ascorbic acid, Fragrance, CI 42053.
- PURPOSE
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WARNINGS
Warnings: 1. In case of having following symptoms after using this product, you're advised to stop using it immediately. If you keep using it, the symptoms will get worse and need to consult a dermatologist . 1) In case of having problems such as red rash, swollenness, itching, stimulation during usage. 2) In case of having the same symptoms above on the part you put this product on by direct sunlight. 2. You are banned to use it on the part where you have a scar, eczema, or dermatitis. 3. In case of getting it into your eyes, you have to wash it immediately.
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS AND USAGE
- DOSAGE AND ADMINISTRATION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SEAWEED CLEANSING
mineral oil liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:60899-050 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Mineral Oil (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) Mineral Oil 75 mg in 150 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Butylene Glycol (UNII: 3XUS85K0RA) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:60899-050-01 150 mL in 1 CARTON; Type 0: Not a Combination Product 09/01/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 09/01/2013 Labeler - AMAROS CO., LTD. (690338801) Registrant - AMAROS CO., LTD. (690338801) Establishment Name Address ID/FEI Business Operations AMAROS CO., LTD. 690338801 manufacture(60899-050)