Label: BODY PRESCRIPTIONS BUTTER PECAN 65 PERCENT ALCOHOL ANTIBACTERIAL HAND SANITIZER- ethyl alcohol solution

  • 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 March 27, 2021

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  • Active Ingredient

    Alcohol: 65% (v/v)

  • Purpose

    Antiseptic

  • Use

    ■ To decrease bacteria on the skin that could cause disease
    ■Recommended for repeated use

  • WARNINGS

    For external use only

    Flammable. Keep away from heat or flame

    Do not use

    in children less than two months of age

    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

    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 at 1-800-222-1222

  • Directions

    Wet hands thoroughly with product and allow to dry without wiping

    For children under 6, use only under adult supervision

    Not recommended for infants

  • Other information

    Do not store above 105F

    May discolor some fabrics

    Harmful to wood finishes and plastics

    Not tested on animals

    For adult use only

  • Inactive ingredients

    Carbomer, Fragrance, Glycerin, PEG-40 Hydrogenated Castor Oil, Red 4, Triehtanolamine, Water, Yellow 5

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    BODY PRESCRIPTIONS BUTTER PECAN 65 PERCENT ALCOHOL ANTIBACTERIAL HAND SANITIZER 
    ethyl alcohol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50563-434
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL65 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50563-434-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product03/27/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/27/2021
    Labeler - ENCHANTE ACCESSORIES INC. (186050696)
    Establishment
    NameAddressID/FEIBusiness Operations
    Xiamen Afgamarine Biotechnology Co., Ltd.420485152manufacture(50563-434)
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