Label: DR. S. WONGS ACNE TREATMENT SULPHUR - sulfur soap
- NDC Code(s): 58929-300-00
- Packager: International Pharmaceuticals, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
NOTE: Most over the counter (OTC) are not reviewed and approved by the 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
Active Ingredients (in each tablet) Purpose
Sulfur 3% .......................................................................Acne TreatmentClose
For the management of acne. Penetrates pores to control acne blemishes, blackheads and whiteheads.Close
WARNINGS For external use only.
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 the eyes.
If excessive skin irritation develops or increases, discontinue use and consult a doctor.
- DOSAGE & ADMINISTRATION
Work up soap into a rich lather. Cover up the entire affected area with a thin layer. Leave on skin for two to three minutes. Rinse well and pat dry.
Because excessive drying of the skin 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.Close
- STORAGE AND HANDLING
Store at room temperature.Close
- INACTIVE INGREDIENT
Fragrance, Soap base: Blend of Sodium Palmate and Sodium Palm Kemalate.Close
International Pharmaceuticals, Inc
Juan Luna Ave., Mabolo, Cebu City, Philippines
Product of the Philippines
- PRINCIPAL DISPLAY PANEL
DR. S. WONG'S
ACNE TREATMENT SULPHUR SOAP
Net Wt. 4.76 oz (135 g)Close
- INGREDIENTS AND APPEARANCE
DR. S. WONGS ACNE TREATMENT SULPHUR
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58929-300 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR 3 g in 100 g Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58929-300-00 135 g in 1 CARTON Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333 05/24/2010 Labeler - International Pharmaceuticals, Inc. (718692460) Registrant - International Pharmaceuticals, Inc. (718692460) Establishment Name Address ID/FEI Business Operations International Pharmaceuticals, Inc. 718692460 manufacture