Label: SAFE AND SILKY NATURAL HAND SANITIZER- safe and silky fragrance hs lotion

  • 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 22, 2020

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  • Safe & Silky Natural Hand Sanitizer

    Active Ingredients

    Active Ingredients: Benzalkonium chloride 0.13% 

    Purpose

    Purpose: hand sanitizer

    Use

    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.

    Do not use in children less than 2 months of age or on open skin wounds.

    When using this product keep out of eyes, ears, and mouth. 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.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

    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 15-30°C (59-86°F)

    Avoid freezing and excessive heat above 40°C (104°F)

    Inactive Ingredients

    water, corn starch, soybean oil, petrolatum, pectin, xanthan gum, citricidal, tributyl phosphate, methyl paraben, propyl paraben, vitamin E acetate, white linen fragrance

    Questions

  • 275 Gallon Tote - Safe & Silky Fragrance Hand Sanitizer - Label

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  • 55 Gallon Drum - Safe & Silky Natural Hand Sanitizer - Label

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  • 330 Gallon Tote - Safe & Silky Natural Hand Sanitizer - Label

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  • 1 Gallon Jug - Safe & Silky Natural Hand Sanitizer - Label

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  • 2OZ Bottlel - Safe & Silky Fragrance Hand Sanitizer - Label

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  • 4OZ Bottlel - Safe & Silky Fragrance Hand Sanitizer - Label

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  • 8OZ Bottlel - Safe & Silky Fragrance Hand Sanitizer - Label

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  • 5 Gallon Pail - Safe & Silky Fragrance Hand Sanitizer - Label

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  • INGREDIENTS AND APPEARANCE
    SAFE AND SILKY NATURAL HAND SANITIZER 
    safe and silky fragrance hs lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78235-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE.13 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CORN STARCH 3-E-DODECENYL SUCCINIC ANHYDRIDE MODIFIED (UNII: QG4MW19XYX)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    PECTIN (UNII: 89NA02M4RX)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    GRAPEFRUIT SEED OIL (UNII: 598D944HOL)  
    TRIBUTYL PHOSPHITE (UNII: 498030B4AD)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78235-010-013785 mL in 1 JUG; Type 0: Not a Combination Product10/06/2020
    2NDC:78235-010-02208175 mL in 1 DRUM; Type 0: Not a Combination Product10/06/2020
    3NDC:78235-010-0318927.1 mL in 1 CONTAINER; Type 0: Not a Combination Product10/06/2020
    4NDC:78235-010-041249050 mL in 1 CONTAINER; Type 0: Not a Combination Product10/06/2020
    5NDC:78235-010-051040875 mL in 1 CONTAINER; Type 0: Not a Combination Product10/09/2020
    6NDC:78235-010-0660 mL in 1 CONTAINER; Type 0: Not a Combination Product10/09/2020
    7NDC:78235-010-07118 mL in 1 CONTAINER; Type 0: Not a Combination Product10/09/2020
    8NDC:78235-010-08237 mL in 1 CONTAINER; Type 0: Not a Combination Product10/09/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A10/06/2020
    Labeler - CK Polymers LLC (079790285)
    Establishment
    NameAddressID/FEIBusiness Operations
    CK Polymers LLC079790285manufacture(78235-010)
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