Label: RENU LABORATORIES ACNE SULPHUR L- acne sulfur lotion suspension
- NDC Code(s): 76348-450-02
- Packager: Renu Laboratories, Inc.
- Category: HUMAN OTC DRUG LABEL
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 January 17, 2022
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
-
DOSAGE & ADMINISTRATION
Directions
- shake well
- 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
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
RENU LABORATORIES ACNE SULPHUR L
acne sulfur lotion suspensionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76348-450 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR 1.4 g in 14 g Inactive Ingredients Ingredient Name Strength FERRIC OXIDE RED (UNII: 1K09F3G675) WATER (UNII: 059QF0KO0R) MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC) ZINC OXIDE (UNII: SOI2LOH54Z) SALICYLIC ACID (UNII: O414PZ4LPZ) CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) ISOPROPYL ALCOHOL (UNII: ND2M416302) Product Characteristics Color white (Suspension) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76348-450-02 56 g in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 04/16/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 04/16/2015 Labeler - Renu Laboratories, Inc. (945739449) Establishment Name Address ID/FEI Business Operations Renu Laboratories, Inc. 945739449 manufacture(76348-450)