Label: SWET PROTECT- alcohol gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 October 2, 2020

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  • Drug Facts

  • Active Ingredient & Purpose

    Active ingredientPurpose
    Alcohol 70% v/v.................................................................................................................Antiseptic
  • Uses

    Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

  • Warnings

    For external use only. Flammable. Keep away from heat or flame

    Do not use

    • on children less than 2 months of age
    • on open skin wounds

    When using this product

    When using this product keep out of eyes. In case of contact with eyes, rinse eyes thoroughly with water.

    Stop use and ask a doctor if

    irritation or rash occurs. These may be signs of a serious condition.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • place enough product on hands to cover all surfaces. Rub hands together until dry.
    • supervise children under 6 years of age when using this product to avoid swallowing.
  • Other information

    • store between 68-77˚F (20-25˚C)
    • do not expose to excessive heat

    Bottle & Tube Product: TAMPER EVIDENT: Do not use if clear seal under cap is torn or missing.

    Pouch Produt:TAMPER EVIDENT: Do not use if pouch is punctured or torn.

  • Inactive ingredients

    2-methyl-2-methylamino-1-propanol, aminomethyl propanol, oat, carbomer 940, fragrance, honey, polyacrylic acid, propylene glycol, potassium sorbate, sodium benzoate, water.

  • Questions or comments?

    +1-844-512-4626 (M-F) 9AM to 5 PM CDT or www.s-wet.com.mx

  • Package Label - Principal Display Panel

    2 fl oz (60 mL) NDC 79827-100-02 (Bottle)
    5.1 fl oz (150 mL) NDC 79827-100-05 (Tube)
    6 fl oz (180 mL) NDC 79827-100-06 (Bottle)
    6.8 fl oz (200 mL) NDC 79827-100-07 (Bottle)
    13.5 fl oz (400 mL) NDC 79827-100-14 (Bottle)
    6.8 fl oz (200 mL) NDC 79827-100-08 (Pouch)

    2 fl oz

    5 fl oz

    6 fl oz

    6.8 fl oz

    13.5 fl oz

    6 fl oz Pouch

  • INGREDIENTS AND APPEARANCE
    SWET PROTECT 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79827-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    OAT (UNII: Z6J799EAJK)  
    POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    2-METHYL-2-METHYLAMINO-1-PROPANOL (UNII: UHE79J5KHU)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    HONEY (UNII: Y9H1V576FH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79827-100-0260 mL in 1 BOTTLE; Type 0: Not a Combination Product09/18/2020
    2NDC:79827-100-05150 mL in 1 TUBE; Type 0: Not a Combination Product09/18/2020
    3NDC:79827-100-06180 mL in 1 BOTTLE; Type 0: Not a Combination Product09/18/2020
    4NDC:79827-100-07200 mL in 1 BOTTLE; Type 0: Not a Combination Product09/18/2020
    5NDC:79827-100-14400 mL in 1 BOTTLE; Type 0: Not a Combination Product09/18/2020
    6NDC:79827-100-08200 mL in 1 POUCH; Type 0: Not a Combination Product09/18/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/18/2020
    Labeler - Energía 5 Mas 1 Comercio, S.A. de C.V. (814860128)
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