Label: UTILIDERM ACNE CONTROL- sulfur,resorcinol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 71493-001-25 - Packager: Sante Naturelle (A.G.) Ltee
- 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 March 24, 2018
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Directions
■ clean the skin thoroughly before applying this product
■ cover the entire affected area with a thin layer one to
three times daily ■ 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.
- INFORMATION FOR PATIENTS
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
UTILIDERM ACNE CONTROL
sulfur,resorcinol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71493-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR 4 mg in 100 mL RESORCINOL (UNII: YUL4LO94HK) (RESORCINOL - UNII:YUL4LO94HK) RESORCINOL 2 mg in 100 mL Inactive Ingredients Ingredient Name Strength BERGAMOT OIL (UNII: 39W1PKE3JI) MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K) NIGELLA SATIVA SEED OIL (UNII: CS4U38E731) OLIVE OIL (UNII: 6UYK2W1W1E) POLYSORBATE 80 (UNII: 6OZP39ZG8H) SORBITAN (UNII: 6O92ICV9RU) CHITOSAN MEDIUM MOLECULAR WEIGHT (200-400 MPA.S) (UNII: 5GV09YMO52) BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) ORIGANUM VULGARE SUBSP. HIRTUM WHOLE (UNII: 38SNL0F81Z) CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) Product Characteristics Color yellow (light) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71493-001-25 1 in 1 CARTON 04/02/2018 1 25 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 04/02/2018 Labeler - Sante Naturelle (A.G.) Ltee (207933979) Registrant - Delta Pharma Inc (200161730) Establishment Name Address ID/FEI Business Operations Delta Pharma Inc. 200161730 manufacture(71493-001)