Label: BALANCING ACT- salicylic acid 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 April 5, 2023

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

  • Active ingredient

    Salicylic acid  0.5%

  • Purpose

    Acne treatment

  • Uses

    For the treatment of acne.

  • 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. Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

    Stop use and ask doctor if skin irritation occurs.

    Keep out of reach of children. If product is swallowed get medical help or contact a poison control center right away.

  • KEEP OUT OF REACH OF CHILDREN

  • Direction

    After cleansing, apply one to two pumps on dry skin. Cover your entire face, not just the visible acne, and avoid the eye area. Let it dry before applying other products. Because irritation or excessive drying of the skin may occur, start with one application every other day, and work up to using daily. Follow with SPF when using in the morning. Reduce application if irritation occurs.

  • Inactive ingredients

    water, diethylene glycol monoethyl ether, mandelic acid, butylene glycol, lactic acid, unspecified form, niacinamide, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer(100000 mpa.s at 1.5%), sodium acrylates crosspolymer-2, sodium pyrrolidone carboxylate, hyaluronate sodium, glycerin, zinc pidolate, gluconolactone, maltodextrin, polysorbate 20, lecithin, soybean, syringa vulgaris pollen, milk thistle, green tea leaf, white tea, aspalathus linearis leaf, glycyrrhiza glabra, centella asiatica triterpenoids, asian ginseng, salix alba bark, arctium lappa root, azadirachta indica leaf, sunflower oil, glycyrrhizinate dipotassium, panthenol, allantoin, tocopherol, sodium hydroxide, caprylyl glycol, ethylhexylglycerin, hexylene glycol, phenoxyethanol, sodium benzoate, potassium sorbate, sorbitan isostearateonic

  • Other information

    Made in USA 

    Distributed by Parea, Inc.

    New York, NY 10013 USA

    becoolasacucumber.com 

  • Product label

    image description

  • INGREDIENTS AND APPEARANCE
    BALANCING ACT 
    salicylic acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83360-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
    MANDELIC ACID (UNII: NH496X0UJX)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
    SODIUM ACRYLATES CROSSPOLYMER-2 (UNII: D3HPR4WW6F)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ZINC PIDOLATE (UNII: C32PQ86DH4)  
    GLUCONOLACTONE (UNII: WQ29KQ9POT)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    SYRINGA VULGARIS POLLEN (UNII: 2BO2QL8OR1)  
    MILK THISTLE (UNII: U946SH95EE)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    WHITE TEA (UNII: O0M3396E09)  
    ASPALATHUS LINEARIS LEAF (UNII: H7UGK1GJCU)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    CENTELLA ASIATICA TRITERPENOIDS (UNII: 4YS74Q4G4J)  
    ASIAN GINSENG (UNII: CUQ3A77YXI)  
    SALIX ALBA BARK (UNII: 205MXS71H7)  
    ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)  
    AZADIRACHTA INDICA LEAF (UNII: HKY915780T)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    ALLANTOIN (UNII: 344S277G0Z)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83360-001-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product04/06/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D04/06/2023
    Labeler - Parea, Inc. (118943804)