Label: HAND RELIEF- lotion 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 August 8, 2023

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  • ACTIVE INGREDIENT

    Ethanol 70% v/v

  • PURPOSE

    Antimicrobial

  • WARNINGS

    For external use only. Flammable. Keep away from children.

  • WHEN USING

    Do not use in or near eyes. In case of eye contact, rinse thoroughly with water.

  • STOP USE

    If redness or irritation develop and persist for more than 72 hours.

  • KEEP OUT OF REACH OF CHILDREN

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

  • INDICATIONS & USAGE

    Apply lotion directly onto body and rub with hands until dry. Product may be used on all skin surfaces. Children under 6 years of age should be supervised when using this product.

  • DOSAGE & ADMINISTRATION

    Apply lotion directly onto body and rub with hands until dry. Product may be used on all skin surfaces. Children under 6 years of age should be supervised when using this product.

  • OTHER SAFETY INFORMATION

    Do not store above 110oF (43oC). For additional information, see Safety Data Sheet (SDS).

  • INACTIVE INGREDIENT

    Water (aqua), glycereth-18 (and) glycereth-18 ethylhexanoate, PEG 1450, PEG-10 dimethicone, ethylene glycol distearate, PEG 75 lanolin, cocamide MEA, retinyl palmitate (Vitamin A), magnesium ascorbyl phosphate (Vitamin C), d-l alpha tocopherol acetate (Vitamin E), acrylate crosspolymer, 2-amino-2-methyl-1-propanol, Cocos nucifera (Coconut oil), mentha piperita extract. 

  • SPL UNCLASSIFIED SECTION

  • SPL UNCLASSIFIED SECTION

  • QUESTIONS

    Call 1-888-300-1225, Monday through Friday 8:00AM to 5:00PM EST/EDT.

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  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    HAND RELIEF 
    lotion lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70741-012
    Route of AdministrationTopical
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R) 25 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70741-012-06960 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/08/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/08/2023
    Labeler - Derma Glove (962709569)
    Registrant - Derma Glove (962709569)
    Establishment
    NameAddressID/FEIBusiness Operations
    RWM Technologies626626969manufacture(70741-012)
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