Label: ACNE CONTROL ESSENCE cream
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Contains inactivated NDC Code(s)
NDC Code(s): 80377-012-01 - Packager: Shenzhen Rongchuang Zhiyuan Industrial Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 September 3, 2020
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INGREDIENTS AND APPEARANCE
ACNE CONTROL ESSENCE
acne control essence creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:80377-012 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 5 g in 100 g REHMANNIA GLUTINOSA ROOT (UNII: 1BEM3U6LQQ) (REHMANNIA GLUTINOSA ROOT - UNII:1BEM3U6LQQ) REHMANNIA GLUTINOSA ROOT 2 g in 100 g SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S) (SCUTELLARIA BAICALENSIS ROOT - UNII:7J95K7ID2S) SCUTELLARIA BAICALENSIS ROOT 2 g in 100 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 5 g in 100 g Inactive Ingredients Ingredient Name Strength CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) XANTHAN GUM (UNII: TTV12P4NEE) MELIA AZEDARACH LEAF (UNII: 8194E3H7D4) GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) GLYCOLIC ACID (UNII: 0WT12SX38S) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:80377-012-01 50 g in 1 BOTTLE; Type 0: Not a Combination Product 09/03/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 09/03/2020 Labeler - Shenzhen Rongchuang Zhiyuan Industrial Co., Ltd. (554538466)
