Label: BODY PRESCRIPTIONS HAND SANITIZER TRIO SPEARMINT UNSCENTED CITRUS- alcohol kit

  • 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 September 16, 2020

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  • BODY PRESCRIPTIONS ANTIBACTERIAL HAND SANITIZER Spearmint

    BODY PRESCRIPTIONS ANTIBACTERIAL HAND SANITIZER Spearmint

    Active Ingredient

    Alcohol 75%

    Purpose

    Antiseptic

  • Use

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

  • WARNINGS

    For external use only, Hands

    Flammable. Keep away from heat and flame

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

    Avoid contact with broken skin

    Do not inhale or ingest

    Stop Use

    Stop use and ask a doctor if skin irritation develops

    keep out of reach of children

    Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a poison control center immediately

  • 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

  • Inactive ingredients

    Water, Glycerin, PEG-40 Hydrogenated Castor Oil, Carbomer, Triethanolamine, Aloe Barbadensis Leaf Extract, Blue 1, Yellow 5

  • BODY PRESCRIPTIONS ANTIBACTERIAL HAND SANITIZER Unsented

    BODY PRESCRIPTIONS ANTIBACTERIAL HAND SANITIZER Unscented

  • ACTIVE INGREDIENT

    Active Ingredient

    Alcohol 75%

  • PURPOSE

    Purpose:

    Antiseptic

  • INDICATIONS & USAGE

    Uses:

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

  • Warnings

    For external use only, Hands

    Flammable. Keep away from heat and flame

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

    Avoid contact with broken skin

    Do not inhale or ingest

  • Stop Use

    Stop use and ask a doctor if skin irritation develops

  • Keep out of reach of children

    Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a poison control center immediately

  • 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

  • Inactive Ingredients

    Water, Glycerin, PEG-40 Hydrogenated Castor Oil, Carbomer, Triethanolamine, Aloe Barbadensis Leaf Extract, Red 33, Blue 1

  • BODY PRESCRIPTIONS ANTIBACTERIAL HAND SANITIZER Citrus

    BODY PRESCRIPTIONS ANTIBACTERIAL HAND SANITIZER Citrus

  • Active Ingredient

    Alcohol 75%

  • Purpose

    Antiseptic

  • Uses

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

  • Warnings

    For external use only, Hands

    Flammable. Keep away from heat and flame

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

    Avoid contact with broken skin

    Do not inhale or ingest

  • Stop Use

    Stop use and ask a doctor if skin irritation develops

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a poison control center immediately

  • 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

  • Inactive Ingredients

    Water, Glycerin, PEG-40 Hydrogenated Castor Oil, Carbomer, Triethanolamine, Aloe Barbadensis Leaf Extract, Yellow 5, Red 4

  • PRINCIPAL DISPLAY PANEL

    image description

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    BODY PRESCRIPTIONS HAND SANITIZER TRIO SPEARMINT UNSCENTED CITRUS 
    alcohol kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50563-256
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50563-256-011 in 1 KIT09/11/2020
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE 60 mL
    Part 21 BOTTLE 60 mL
    Part 31 BOTTLE 60 mL
    Part 1 of 3
    BODY PRESCRIPTIONS ANTIBACTERIAL HAND SANITIZER SPEARMINT 
    alcohol solution
    Product Information
    Item Code (Source)NDC:50563-253
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50563-253-0160 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/11/2020
    Part 2 of 3
    BODY PRESCRIPTIONS ANTIBACTERIAL HAND SANITIZER UNSCENTED 
    alcohol solution
    Product Information
    Item Code (Source)NDC:50563-254
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50563-254-0160 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/11/2020
    Part 3 of 3
    BODY PRESCRIPTIONS ANTIBACTERIAL HAND SANITIZER CITRUS 
    alcohol solution
    Product Information
    Item Code (Source)NDC:50563-255
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50563-255-0160 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/11/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/11/2020
    Labeler - ENCHANTE ACCESSORIES INC. (186050696)
    Establishment
    NameAddressID/FEIBusiness Operations
    Xiamen Afgamarine Biotechnology Co., Ltd.420485152manufacture(50563-256)
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