RAW SUGAR HAND SANITIZER- PEPPERMINT AND SEA SALT. (ALCOHOL) GEL [BOLERO HOME DECOR, INC.]

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  • RAW SUGAR HAND SANITIZER- PEPPERMINT AND SEA SALT. (ALCOHOL) GEL [BOLERO HOME DECOR, INC.]

RAW SUGAR HAND SANITIZER- PEPPERMINT AND SEA SALT. (ALCOHOL) GEL [BOLERO HOME DECOR, INC.]
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NDC 57469-065-01
Set ID 3dda880f-d874-46cd-939b-f350a850194d
Category HUMAN OTC DRUG LABEL
Packager Bolero Home Decor, Inc.
Generic Name
Product Class
Product Number
Application Number PART333A
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  • Active ingredient:

    Organic Alcohol 62%.

  • Purpose:

    Antimicrobial.

  • Uses

    • Hand Sanitizing to reduce bacteria on the skin that could cause disease.
    • Recommended for repeated use.
  • Warnings:

    ​Flammable. Keep away from fire or flame.

    ​For external use only.

    Avoid contact with eyes.

    In case of eye contact, flush eyes with water.

    Stop use and see a doctor if

    irritation or redness develops, or if condition persist for more than 72 hours.

    Keep out of reach of childre.

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

  • Directions

    • ​Place enough product in your palm to throughly cover your hands.
    • Rub hands together briskly until dry.
    • Children under the age of 6 should be supervised when using this product.
  • Other Information

    • Store at 20-25 ​0C (68-77 ​0F)
    • May discolor certain fabrics or surfaces.
  • Inactive Ingredients

    Purified Water (Agua), Aminomethyl Propanol, Carbomer, Fragrance (Parfum), Polysorbate 20, Cocos Nucifera (Coconut) Fruit Extract*, Citrus Limon (Lemon) Fruit Extract*, Verbena Officinalis (Ginger) Root Extract*, Symphytum Officinale Extract*, Hibiscus Sabdariffa Flower Extract*.

    *Certified Organic.

  • Raw Sugar Hand Sanitizer- Peppermint and Sea Salt.

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  • INGREDIENTS AND APPEARANCE
    RAW SUGAR HAND SANITIZER- PEPPERMINT AND SEA SALT. 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57469-065
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.62 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    COCOS NUCIFERA WHOLE (UNII: 245J88W96L)  
    CITRUS LIMON FRUIT OIL (UNII: 0HNC1J1YED)  
    ZINGIBER OFFICINALE WHOLE (UNII: IN6Q3S3414)  
    SYMPHYTUM OFFICINALE WHOLE (UNII: H8FJJ6KX5Y)  
    HIBISCUS SABDARIFFA FLOWER (UNII: 45TGG6IU6M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57469-065-01266 mL in 1 PACKAGE; Type 0: Not a Combination Product09/23/201610/01/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/23/201610/01/2022
    Labeler - Bolero Home Decor, Inc. (067967365)
    Registrant - Bolero Home Decor, Inc. (067967365)
    Establishment
    NameAddressID/FEIBusiness Operations
    Product Packaging West, Inc.847033677manufacture(57469-065)
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