Label: RED BETTER SPOT CORRECTOR NON-DRYING ACNE BALM- salicylic acid, sulfur cream

  • 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 May 29, 2017

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

  • ACTIVE INGREDIENT

    Active Ingredient
    Salicylic Acid 2.0%
    Sulfur 1.00%

    PDP

  • PURPOSE

    Purpose

    Acne Treatment

  • INDICATIONS & USAGE

    Uses  Treats acne  Clears acne blemishes  Helps prevent development
    of new acne blemishes

  • WARNINGS

    Warnings
    For external use only
    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.
    Keep out of reach of children, if swallowed, get medical help or contact a Poison
    Control Center right away.

    Do not use on
     broken skin
     large areas of the skin
    When using this product apply only to areas with acne.

  • DOSAGE & ADMINISTRATION

    Directions
     As needed, dot a tiny amount on affected areas and spread gently.
     If condition worsens, see a dermatologist.

  • OTHER SAFETY INFORMATION

    Other Information
     Before use, test a tiny amount on skin (we omit allergens, but you may be sensitive
    to an ingredient that is not an allergen.
     Introduce new skin products one at a time, with at least 3 days in between.
     Do not introduce removed portions of product or other substances into container.
     Do not store in extreme temperatures.
     If contact with eyes occurs, flush out with plenty of water.
     Stop use and consult your doctor in the unlikely event of discomfort, if condition
    worsens or lasts longer than two weeks, and immediately if signs of infection appear.
     As with all things skin, consult your dermatologist.

  • INACTIVE INGREDIENT

    Inactive Ingredients

    Aqua/Water/Eau, Butylene Glycol, Cetearyl Alcohol, Ceteareth-25, Glyceryl Stearate,
    C12-15 Alkyl Lactate, Alcohol, Glyceryl Laurate, Cyclopentasiloxane, Camellia Sinensis
    Leaf Extract, Sulfur, PEG-30 Castor Oil, 1,2-Hexanediol, Caprylyl Glycol, Sodium
    Phytate.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children, if swallowed, get medical help or contact a Poison
    Control Center right away.

  • PRINCIPAL DISPLAY PANEL

    PDP

    VMV HYPOALLERGENICS
    validated hypoallergenic.
    randomized, blinded, published &
    awarded clinical studies. since 1979

    RED BETTER
    SPOT CORRECTOR
    non-drying acne balm

    Redness + angry
    skin-calming system

    monolaurin + other inflammation reducers
    keratolytic comedolytic sulfur +
    salicylic acid; silicones;
    soothing antioxidants

    Validated
    Hypoallergenic:
    VH -109/109
    sans all common allergens,
    extended allergen series:
    North American Contact Dermatitis
    Group + European Surveillance
    System on Contact Allergies

    100% All-Types-Of-Fragrance-Free.

    100% Dye, Phthalate, Paraben + Preservative-Free.

    Usage, Patch + Clinically-Tested (in vitro + in vivo)

    For All Skin Types; for angry, quickly-triggered skin.

    Non-Drying. Non-Comedogenic.

    For Men + Women.

    8 g (0.28 Oz.) - 8g

  • INGREDIENTS AND APPEARANCE
    RED BETTER SPOT CORRECTOR NON-DRYING ACNE BALM 
    salicylic acid, sulfur cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69774-944
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR0.08 g  in 8 g
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.16 g  in 8 g
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETEARETH-25 (UNII: 8FA93U5T67)  
    C12-15 ALKYL LACTATE (UNII: GC844VRD7E)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    PHYTATE SODIUM (UNII: 88496G1ERL)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    GLYCERYL LAURATE (UNII: Y98611C087)  
    PEG-30 CASTOR OIL (UNII: GF873K38RZ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69774-944-021 in 1 BOX05/30/2017
    18 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D05/30/2017
    Labeler - SKIN SCIENCES LABORATORY INC. (718777360)