Label: ELFMINERAL BLEMISH KIT BOX- sulfur powder
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Contains inactivated NDC Code(s)
NDC Code(s): 52664-006-01 - Packager: Hangzhou Facecare Cosmetics Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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 November 17, 2010
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- WHEN USING
- ASK DOCTOR
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
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INACTIVE INGREDIENT
Inactive Ingredient:
Zince Stearate, Barium Sulfate, Silica, Kaolin, Dimethicone/Vinyl Dimethicone Crosspolymer, Corn Starch Modified, Alba (Willow) Bark Extract, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Dextrin, Magnesium Myristate, Calcium Sodium Phosphosilicate, Mica, Bismuth Oxychloride, Titanium Dioxide
May contain:
Iron Oxides (CI 77491, CI 77492, CI 77499)
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ELFMINERAL BLEMISH KIT BOX
sulfur powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52664-006 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR 3 g in 100 g Inactive Ingredients Ingredient Name Strength ZINC STEARATE (UNII: H92E6QA4FV) 41.4 g in 100 g BARIUM SULFATE (UNII: 25BB7EKE2E) 35.0 g in 100 g SILICON DIOXIDE (UNII: ETJ7Z6XBU4) KAOLIN (UNII: 24H4NWX5CO) WILLOW BARK (UNII: S883J9JDYX) TEA TREE OIL (UNII: VIF565UC2G) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) ALFADEX (UNII: Z1LH97KTRM) MICA (UNII: V8A1AW0880) BISMUTH OXYCHLORIDE (UNII: 4ZR792I587) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52664-006-01 3.3 g in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 12/01/2010 Labeler - Hangzhou Facecare Cosmetics Co., Ltd. (545341856) Registrant - Hangzhou Facecare Cosmetics Co., Ltd. (545341856) Establishment Name Address ID/FEI Business Operations Hangzhou Facecare Cosmetics Co., Ltd. 545341856 manufacture