Label: ANTIPERSPIRANT WIPE FOR WOMEN- aluminum chlorohydrate swab

  • NDC Code(s): 71592-001-85, 71592-001-86
  • Packager: FlawlessWipes, LLC
  • 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 17, 2017

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  • ACTIVE INGREDIENT

    Aluminum Chlorohydrate 15%

  • Purpose

    Antiperspirant

  • USES

    Underarm antiperspirant to reduce perspiration and odor

  • WARNINGS

    • For external use only
    • When using this product avoid contact with eyes. in case of eye contact, flush thoroughly with water.
    • Discontinue use and contact a doctor if irritation and redness develop and conditions persist for more than 72 hours
  • KEEP OUT OF REACH OF CHILDREN

    If swallowed, get medical help or contact a poison control center right away

  • DIRECTIONS

    Open packet, remove and unfold wipe, apply to underarm only, dispose of used wipe in the trash, do not flush.

  • Inactive ingredients

    Water, polysorbate 20, Salvia Officinalis (Sage) Leaf Extract, Usnea Barbata (Lichen) extract, Tocopherol, Tocopheryl Acetate, PEG-180, Phenoxyethanol, Benzyl Alcohol, Potassium Sorbate, Fragrance

  • Pakaging

    Label

  • INGREDIENTS AND APPEARANCE
    ANTIPERSPIRANT WIPE FOR WOMEN 
    aluminum chlorohydrate swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71592-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALUMINUM CHLOROHYDRATE (UNII: HPN8MZW13M) (ALUMINUM CHLOROHYDRATE - UNII:HPN8MZW13M) ALUMINUM CHLOROHYDRATE15 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    USNEA BARBATA (UNII: D6DVA9TCAP)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    SAGE (UNII: 065C5D077J)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)  
    Product Characteristics
    ColorwhiteScore    
    ShapeRECTANGLESize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71592-001-866 in 1 PACKAGE07/18/2017
    1NDC:71592-001-853 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35007/18/2017
    Labeler - FlawlessWipes, LLC (080676003)
    Registrant - FlawlessWipes, LLC (080676003)
    Establishment
    NameAddressID/FEIBusiness Operations
    Diamond Wipes International, Inc.161104729manufacture(71592-001)
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