Label: BOTANIC HEAL BOH ACNE SENSITIVE FO AM CLEANSER- salicylic acid gel

  • 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 August 7, 2017

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  • ACTIVE INGREDIENT

    Active ingredients: SALICYLIC ACID 0.50%

  • INACTIVE INGREDIENT

    Inactive ingredients: WATER,MYRISTIC ACID,GLYCERIN,POTASSIUM HYDROXIDE,PROPYLENE GLYCOL,STEARIC ACID,LAURIC ACID,PEG-75,GLYCERYL STEARATE,PEG-100 STEARATE,FRAGRANCE,POLOXAMER 184,PHENOXYETHANOL,DISODIUM EDTA

  • PURPOSE

    Purpose: Acne Treatment

  • WARNINGS

    Warnings: For external use only. Avoid contact with eyes. Discontinue use if signs of irritation or rashes appear. Replace the cap after use. Keep Out of Reach of Children.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • Uses

    Uses: Hypo-allergenic foam cleanser that helps to recover the sensitive and acne skin.

  • Directions

    Directions: At the last step of basic skincare, turn the dial on the lower part of the container to raise content by 5mm and lightly apply on the face, starting from the inside and working outward.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of tube

  • INGREDIENTS AND APPEARANCE
    BOTANIC HEAL BOH ACNE SENSITIVE FO AM CLEANSER 
    salicylic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71596-037
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID1.25 g  in 250 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Glycerin (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71596-037-01250 mL in 1 TUBE; Type 0: Not a Combination Product07/01/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D07/01/2017
    Labeler - Cj Olivenetworks Co., Ltd (688271303)
    Registrant - Cj Olivenetworks Co., Ltd (688271303)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kolmar Korea Co., Ltd.689512611manufacture(71596-037)
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