JOESOEF SKINCARE ANTI ACNE- sulfur lotion 
PT Galenium Pharmasia Laboratories

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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Anti-Acne Lotion

Drug Facts

Active Ingredients                     Purpose

Precipitated Sulfur 6.6%..............Acne medication

Use for the treatment of acne. Penetrades pores to clear most acne blemishes, acne pimples, blackhead, and whiteheads. Helps prevent the development of new acne blemishes, blackheads, and whiteheads.

Keep out of reach of children. 

In case of incidental ingestion, get medical help or contact a poison control center immediately.

Directions

Warnings

For external use only

When using this product

Inactive ingredients

Purified water, Ethyl alcohol, DMDM Hydantoin, Cabomer, Fragrance, Triethanolamine, Calcium oxide.

image description

JOESOEF SKINCARE ANTI ACNE 
sulfur lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:26050-112
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR6.3   in 95 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
CARBOMER 1342 (UNII: 809Y72KV36)  
TRIETHANOLAMINE BENZOATE (UNII: M3EN4GC19W)  
LIME (CALCIUM OXIDE) (UNII: C7X2M0VVNH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:26050-112-0195 mL in 1 BOTTLE; Type 0: Not a Combination Product10/01/2006
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D10/01/2006
Labeler - PT Galenium Pharmasia Laboratories (726631497)
Establishment
NameAddressID/FEIBusiness Operations
PT Galenium Pharmasia Laboratories726631497manufacture(26050-112)

Revised: 2/2020
Document Id: 9f6861c8-6d8a-4567-e053-2995a90aa25c
Set id: be8a5e8c-18c7-4dc8-a19c-99c963700c1d
Version: 4
Effective Time: 20200225
 
PT Galenium Pharmasia Laboratories