KATE SUMMERVILLE ERADIKATE- sulfur cream 
Beauty Manufacturing Solutions Corp.

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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Kate Summerville EradiKate

Sulfur 3.0%

Purpose: Anti-Acne active ingredient

Acne Treatment

For external use only.

Skin irritation or dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.

if rash occurs.

If swallowed, get medical help or contact a Posion Control Center right away.

Aqua/Water/Eau, Sodium Cocoyl Isethionate, Coco-Glucoside, Acrylates Copolymer, Coconut Alcohol, Glycereth-18 Ethylhexanoate, Glycereth-18, Stearyl Alcohol, Honey Extract, Oryza Sativa (Rice) Bran Extract, Avena Sativa (Oat) Kernel Extract, Oligopeptide-10, Boswellia Serrata Extract, Behenyl Alcohol, Glycerin, Xanthan Gum, Caprylyl Glycol, Hexylene Glycol, Butylene Glycol, Phenoxyethanol, Fragrance (Parfum), Citric Acid, Sodium Hydroxide, Ethylhexylglycerin, Disodium EDTA, Disodium Carboxyethyl Siliconate, Titanium Dioxide (CI 77891), Iron Oxides (CI 77491)

Store in a cool, dry place. Avoid product contactwith silver jewelry, which may be discolored by this product.

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KATE SUMMERVILLE ERADIKATE 
sulfur cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11090-263
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR3 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
OLIGOPEPTIDE-10 (UNII: Q46328TRNK)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)  
DOCOSANOL (UNII: 9G1OE216XY)  
GLYCERETH-18 ETHYLHEXANOATE (UNII: IWS58C6V2Y)  
OAT BRAN (UNII: KQX236OK4U)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
XANTHAN GUM (UNII: TTV12P4NEE)  
DISODIUM CARBOXYETHYL SILICONATE (UNII: 4U4C79679G)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
HONEY (UNII: Y9H1V576FH)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
COCONUT ALCOHOL (UNII: 13F4MW8Y9K)  
RICE BRAN OIL (UNII: LZO6K1506A)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
GLYCERETH-18 (UNII: SA5E43C17C)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11090-263-021 in 1 BOX02/01/2022
1120 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D02/01/2022
Labeler - Beauty Manufacturing Solutions Corp. (783200723)
Registrant - Beauty Manufacturing Solutions Corp. (783200723)
Establishment
NameAddressID/FEIBusiness Operations
Beauty Manufacturing Solutions Corp.783200723manufacture(11090-263)

Revised: 2/2022
Document Id: d7c14c78-737f-5f38-e053-2a95a90a1ba0
Set id: d4b15ecd-ecdf-a8e0-e053-2995a90ad40a
Version: 2
Effective Time: 20220211
 
Beauty Manufacturing Solutions Corp.