ACNE CONTROL ESSENCE- acne control essence cream 
Shenzhen Rongchuang Zhiyuan Industrial Co., Ltd.

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.

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50g a bottle DNC: 80377-012-01

50g Label

ACNE CONTROL ESSENCE 
acne control essence cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80377-012
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE5 g  in 100 g
REHMANNIA GLUTINOSA ROOT (UNII: 1BEM3U6LQQ) (REHMANNIA GLUTINOSA ROOT - UNII:1BEM3U6LQQ) REHMANNIA GLUTINOSA ROOT2 g  in 100 g
SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S) (SCUTELLARIA BAICALENSIS ROOT - UNII:7J95K7ID2S) SCUTELLARIA BAICALENSIS ROOT2 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80377-012-0150 g in 1 BOTTLE; Type 0: Not a Combination Product09/03/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35209/03/2020
Labeler - Shenzhen Rongchuang Zhiyuan Industrial Co., Ltd. (554538466)

Revised: 9/2020
Document Id: aeee5d13-92b1-bfa9-e053-2995a90ae64d
Set id: aeee6299-9b6e-1a4e-e053-2995a90a7ab2
Version: 1
Effective Time: 20200903
 
Shenzhen Rongchuang Zhiyuan Industrial Co., Ltd.