Label: ROSAACNE RELIEF- sulfur, salicylic acid ointment

  • 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 July 30, 2018

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  • Active Ingredients

    Sulfur         7.1%
    Salicylic Acid           3%

  • Purpose

    Acne Treatment

  • Uses

    For the treatment of acne

  • Warning

    For external use only.

  • When using this product

    1. Some patients may have aggravated symptoms within 10 days of use; but may start to improve after 2 weeks.
    2. The product is recommended to use continuously without interruption.
    3. Skin irritation and dryness are likely to occur if you use another topical acne medication at the same time. If irritation occurs, use only one topical acne product at a time.
    4. Pregnant or breast-feeding women and children use with caution.
    5. Avoid contact with eyes.
    6. If dryness, slight burn feeling or skin peeling occurs, reduce application and use one time a day or every other day.

  • Do not use

    If you are allergic to any ingredient(s) of the product.

  • Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Cleanse the skin thoroughly before applying this product twice a day.

  • Storage

    Keep in a dry, cool place away from direct sunlight.

  • Manufactured by:Kunming Zhongzhou Pharmaceutical Co. LtdNo. 16 Jingdong Road, Kunming, ChinaMade in China

    Distributed exclusively by:
    AL Lauren Corp. Temple City, CA 91780 USA

  • Inactive Ingredients

    Zinc Oxide, Boric Acid, Menthol, Dimethicone, Petrolatum, Stearic Acid, Octadecanol (Mixture of Isomers), Glycerin,
    Glyceryl Monostearate, Water

  • Drug Facts

    image description

  • INGREDIENTS AND APPEARANCE
    ROSAACNE RELIEF 
    sulfur, salicylic acid ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72317-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR7.1 g  in 100 g
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID3 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    Zinc Oxide (UNII: SOI2LOH54Z)  
    Boric Acid (UNII: R57ZHV85D4)  
    Menthol (UNII: L7T10EIP3A)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Petrolatum (UNII: 4T6H12BN9U)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    OCTADECANOL (MIXTURE OF ISOMERS) (UNII: C6BPY2QY39)  
    Glycerin (UNII: PDC6A3C0OX)  
    Glyceryl Monostearate (UNII: 230OU9XXE4)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72317-001-011 in 1 BOX07/18/2018
    120 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D07/18/2018
    Labeler - Kunming Zhongzhou Pharmaceutical Co, Ltd (529561942)
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