Label: CHARM-TEX ANTIPERSPIRANT ROLL-ON DEODORANT- aluminum chlorohydrate 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 January 19, 2012

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Aluminum Chlorohydrate 7.8%

  • Purpose

    Antiperspirant

  • Use

    Reduces underarm perspiration

  • WARNINGS

    For external use only.

    Do not use on broken skin.

    Discontinue use if irritation and redness develop. If condition persists for more than 72 hours consult a doctor.

    Ask a doctor before use if you have kidney disease.

    Keep out of reach of children. If swallowed, get medical help and contact Poison Control Center right away.

  • Directions

    Apply to underarms only.

  • Inactive Ingredients

    Water, Glyceryl Stearate, Peg 100 Stearate, Magnesium, Aluminum, Silicate, Fragrance

  • SPL UNCLASSIFIED SECTION

    Manufactured for:
    CHARM-TEX, INC.
    1618 Coney Island Ave., Brooklyn NY 11230

  • PRINCIPAL DISPLAY PANEL - 44 ml Applicator Label

    Charm-Tex

    ANTIPERSPIRANT
    ROLL-ON
    DEODORANT

    ALCOHOL FREE
    Net Wt. 1.5 oz. 44 ml.

    PRINCIPAL DISPLAY PANEL - 44 ml Applicator Label
  • INGREDIENTS AND APPEARANCE
    CHARM-TEX  ANTIPERSPIRANT ROLL-ON DEODORANT
    aluminum chlorohydrate gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:40057-2001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Aluminum chlorohydrate (UNII: HPN8MZW13M) (Aluminum chlorohydrate - UNII:HPN8MZW13M) Aluminum chlorohydrate7.8 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Glyceryl Monostearate (UNII: 230OU9XXE4)  
    Peg-100 Stearate (UNII: YD01N1999R)  
    Magnesium (UNII: I38ZP9992A)  
    Aluminum (UNII: CPD4NFA903)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:40057-2001-144 mL in 1 APPLICATOR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35001/17/2012
    Labeler - Charm-Tex, Inc (058347543)
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