MINERAL BLEMISH KIT- sulfur powder 
J. A. Cosmetics U.S. INC

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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Active Ingredient:

SULFUR (3%)

Purpose:

ACNE TREATMENT

Uses:

Warning:

For external use only

When Using This Product

Stop use and ask a doctor if

KEEP OUT OF REACH OF CHILDREN.

Directions:

Inactive Ingredient:

MICA, BISMUTH OXYCHLORIDE, ALUMINUM STARCH OCTENYLSUCCINATE, PARAFFINIUM LIQUIDUM (MINERAL OIL), MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL, SODIUM DEHYDROACETATE. MAY CONTAIN: IRON OXIDES (CI 77491, CI 77492, CI 77499)

Mineral Blemish Kit

MINERAL BLEMISH KIT 
sulfur powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76354-205
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR3   in 100 g
Inactive Ingredients
Ingredient NameStrength
MICA (UNII: V8A1AW0880)  
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
MINERAL OIL (UNII: T5L8T28FGP)  
TEA TREE OIL (UNII: VIF565UC2G)  
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76354-205-213.3 g in 1 BOX
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D10/10/2013
Labeler - J. A. Cosmetics U.S. INC (186705047)
Registrant - J. A. Cosmetics U.S. INC (186705047)
Establishment
NameAddressID/FEIBusiness Operations
Shanghai J. A. Cosmetics Trading CO., LTD.421280183manufacture(76354-205)

Revised: 3/2014
Document Id: 17074116-d927-4be7-8556-458e2417165f
Set id: 7d48561b-06e9-4fdd-89c2-6e9deb7bd19b
Version: 3
Effective Time: 20140319
 
J. A. Cosmetics U.S. INC