Label: BORN BASIC. ANTI-BAC HAND SANITIZER 65 PERCENT- 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 July 5, 2020

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  • ACTIVE INGREDIENT

    ETHYL ALCOHOL 65%

  • PURPOSE

    ANTISEPTIC

  • USES

    • DECREASES BACTERIA ON THE SKIN THAT COULD CAUSE DISEASE
    • RECOMMENDED FOR REPEATED USE

  • WARNINGS

    For external use only: hands

    Flammable. Keep away from fire or 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 and ask a doctor if

    • irritation and redness develop
    • condition persists for more than 72 hours
  • Keep out of reach of children.

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

  • 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 105°F
    • MAY DISCOLOR SOME FABRICS
    • HARMFUL TO WOOD FINISHES AND PLASTICS
  • INACTIVE INGREDIENTS

    WATER, GLYCERIN, PROPYLENE GLYCOL, CARBOMER, FRAGRANCE, TRIETHANOLAMINE, ALOE BARBADENSIS (ALOE VERA)

  • PRINCIPAL DISPLAY PANEL

    01b LBL_BB_34FLOZ_GEL_HandSanitizer_LABEL_PROD_V2 65pct

  • INGREDIENTS AND APPEARANCE
    BORN BASIC. ANTI-BAC HAND SANITIZER  65 PERCENT
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76891-105
    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
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76891-105-111000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/11/2020
    2NDC:76891-105-181000 mL in 1 BOTTLE; Type 0: Not a Combination Product03/11/2020
    3NDC:76891-105-191000 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product03/11/2020
    4NDC:76891-105-12500 mL in 1 BOTTLE; Type 0: Not a Combination Product04/30/2020
    5NDC:76891-105-13236 mL in 1 BOTTLE; Type 0: Not a Combination Product04/30/2020
    6NDC:76891-105-14280 mL in 1 BOTTLE; Type 0: Not a Combination Product04/30/2020
    7NDC:76891-105-152011 mL in 1 BOTTLE; Type 0: Not a Combination Product04/30/2020
    8NDC:76891-105-163667 mL in 1 JUG; Type 0: Not a Combination Product04/30/2020
    9NDC:76891-105-172000 mL in 1 JUG; Type 0: Not a Combination Product04/30/2020
    10NDC:76891-105-203780 mL in 1 JUG; Type 0: Not a Combination Product04/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A10/17/2019
    Labeler - SCENT THEORY PRODUCTS LLC (101216246)
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