Label: CLEANSER ACNE CLEARING TREATMENT- benzoyl peroxide liquid

  • 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 20, 2013

If you are a consumer or patient please visit this version.

View All Sections
  • ACTIVE INGREDIENT

    Active Ingredients:                      Purpose:
    Sulphur 5%...........................................Acne medication
  • PURPOSE

    Uses:For the management of acne
    • helps clear up acne blemishes, black heads, helps prevent the development of new acne pimples
    • penetrates pores to reduce the number of acne pimples, white heads and black heads
    • help keep skin clear of new acne pimples, white heads and black heads
    • helps prevent new acne pimples, white heads and black heads from forming
    • help prevent the development of new pimples, white heads and black heads
  • WARNINGS

    Warnings: For external use only. When using this product skin irritation and dryness may occur.

    Do not use
    • if you have sensitive skin and/or are sensitive to Sulphur
    • on broken skin
    • on skin that ha no breakouts
    When using this product
    • skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time
    • avoid unnecessary sun exposure and use sun screen, Acne Clearing Moisture with SPL 45
    • skin irritation may occur, characterized by redness, burning, itching, peeling, and possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration
    Stop use and ask a doctor if
    • irritation becomes severe
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.If swallowed get medical help or contact a Poison Control center immediately.
  • INDICATIONS & USAGE

    Directions:
    • cleanse skin with ACNE CLEARING CLEANSER a benzoyl peroxide acne medication cleansing gel.
    • moisten fresh cotton ball with ACNE CLEARING TONIC a salicylic acid serum medication for oil control.
    • apply ACNE CLEARING TREATMENT 101 a sulphur and natural anti-inflammatory lotion medication to acne breakout areas.
    • start with one application daily then gradually increase to 2 or 3.
    • if going outside after cleansing apply sun screen, Acne Clearing Moisture with SPF 45
    • if excessive irritation or sensitivity develops stop use of both products and contact a physician.
  • INACTIVE INGREDIENT

    Ingredients: Purified Water, Sulfer, Catalase, Aqueous extract of arnica, Glycerin, Cetyl Alcohol, Ceteareth-12, Bromelain, Ultrez 21, Mineral Oil, Ethhylene Glycol, Propylene Glycol, Sodium Ascorbyl Phosphate, Triethanolamine, Ascorbic Acid, Dodecyl Benzene Sulfonate, Peppermint oil, Piperine, Mint Base, EDTA, BHT, BHA, Methylparaben, Propylparaben.
  • DOSAGE & ADMINISTRATION

    2 FL OZ / 60 ml
  • PRINCIPAL DISPLAY PANEL

    label
    Treatment 101
    Acne Clearing Treatment
  • INGREDIENTS AND APPEARANCE
    CLEANSER  ACNE CLEARING TREATMENT
    benzoyl peroxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51439-005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE.006 mg  in .024 mg
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DODECYLBENZENESULFONIC ACID (UNII: 60NSK897G9)  
    ETHYLENE GLYCOL (UNII: FC72KVT52F)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    HAMAMELIS VIRGINIANA LEAF (UNII: T07U1161SV)  
    CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)  
    VITAMIN A (UNII: 81G40H8B0T)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    WEST INDIAN LEMONGRASS OIL (UNII: 5BIA40E9ED)  
    POMEGRANATE (UNII: 56687D1Z4D)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    EDETIC ACID (UNII: 9G34HU7RV0)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51439-005-01.024 mg in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D08/06/2012
    Labeler - CarePluss Pharma S.A. de C.V. (815061551)
    Registrant - CarePluss Pharma S.A. de C.V. (815061551)
    Establishment
    NameAddressID/FEIBusiness Operations
    CarePluss Pharma S.A. de C.V.815061551manufacture(51439-005)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!