Label: JOESOEF SKINCARE ANTI ACNE- sulfur lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 26050-112-01 - Packager: PT Galenium Pharmasia Laboratories
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 February 25, 2020
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- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
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INDICATIONS & USAGE
Directions
- Cleanse the skin thoroughly before applying medication.
- Using a cotton swab, cover the entire effected area with a thin layer one to three times daily.
- Because excessive drying of the skim may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor. If bothersome dryness or peeling occurs, reduce application to once a day or every other day.
- Shake well before use
- WARNINGS
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DOSAGE & ADMINISTRATION
When using this product
- Using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.
- Do not get into eyes. If excessive skin irridation develops or increases, discontinue use and consult a doctor.
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
JOESOEF SKINCARE ANTI ACNE
sulfur lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:26050-112 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR 6.3 in 95 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:26050-112-01 95 mL in 1 BOTTLE; Type 0: Not a Combination Product 10/01/2006 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 10/01/2006 Labeler - PT Galenium Pharmasia Laboratories (726631497) Establishment Name Address ID/FEI Business Operations PT Galenium Pharmasia Laboratories 726631497 manufacture(26050-112)