Label: BATH ELEMENTS ADVANCED HAND SANITIZER PINEAPPLE- 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 7, 2022

If you are a consumer or patient please visit this version.

  • Active Ingredient(s)

    Ethyl Alcohol, 75% v/v. Purpose: Disinfectant

  • Purpose

    Disinfectant

  • Uses

    • Decreases bacteria on skin that could cause diseases.
    • Recommended for repeated use.
  • Warnings

    For external use on hands only.

    Flammable, keep away from flame or fire.

    When using this product

    keep out of eyes, in case of contact with eyes, flush thoroughly with water.

    • Do not ingest or inhale.
    • Avoid contact with broken skin.

    Stop use and ask doctor if

    redness & irritation develop or if condition persists for more than 72 hours.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poision Control Center immediately.

  • DO NOT USE

    • For children under 6, use only with adult supervision.
    • Not recommended for infants.
  • WHEN USING

    When using this product

    keep out of eyes, in case of contact with eyes, flush thoroughly with water.

    • Do not ingest or inhale.
    • Avoid contact with broken skin.
  • STOP USE

    Stop use and ask doctor if

    redness & irritation develop or if condition persists for more than 72 hours

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poision Control Center immediately.

  • Directions

    Spread product on hands thoroughly & allow to dry, do not wipe off.

    • For children under 6, use only with adult supervision.
    • Not recommended for infants.
  • Other information

    Do not store above 105℉ (40.6℃).

    may discolor some fabrics.

    • Harmful to plastics & wood finishes.
  • Inactive ingredients

    water (aqua), carbomer, triethanolamine, fragrance.

  • Package Label - Principal Display Panel

    L201-03

  • INGREDIENTS AND APPEARANCE
    BATH ELEMENTS ADVANCED HAND SANITIZER PINEAPPLE 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82534-201
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL22.5 mL  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    METHYL 3-HYDROXYHEXANOATE (UNII: 8H646ZUC4E)  
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82534-201-0330 mL in 1 BOTTLE; Type 0: Not a Combination Product07/07/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/07/2022
    Labeler - Hangzhou Beite Daily Necessities Co., Ltd. (713301066)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hangzhou Beite Daily Necessities Co., Ltd.713301066manufacture(82534-201)