Label: HARMON DAILY MOISTURZIER- dimethicone lotion

  • NDC Code(s): 63940-074-03, 63940-074-43
  • Packager: HARMON STORES, INC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 14, 2021

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  • Active ingredients

    Dimethicone 1.3%

  • Purpose

    Skin Protectant

  • Uses

    • helps prevent and temporarily protects dry, chafed, cracked, and windburned skin.
  • Warnings

    For external use only

  • Do not use

    • on deep or puncture wounds, infections, or lacerations, Consult a doctor.
  • When using this product

    • Keep out of eyes and eyelids. May stain or damage some fabrics, materials or surfaces.
  • Stop use and ask a doctor if

    • condition worsens or does not improve within seven days.
  • Keep out of reach of children.

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

    • Apply as needed to hands or body when skin feels dry or irritated.
  • Inactive ingredients

    water, glycerin, distearyldimonium chloride, petrolatum, isopropyl palmitate, cetyl alcohol, avena sativa (oat) kernel flour, magnesium aluminum silicate, sodium chloride, benzyl alcohol

  • PRINCIPAL DISPLAY PANEL

    HARMON DAILY MOISTURIZING LOTION WITH NATURAL SOOTHING OATMEAL

    3 OZ (85g)

    NDC 63940-072-03

    Label3

    HARMON DAILY MOISTURIZING LOTION WITH NATURAL SOOTHING OATMEAL

    18 FL OZ (532mL)

    NDC 63940-072-43

    Label18FrontLabel18Back

  • INGREDIENTS AND APPEARANCE
    HARMON DAILY MOISTURZIER 
    dimethicone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63940-074
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE13 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    OATMEAL (UNII: 8PI54V663Y)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63940-074-0385 mL in 1 TUBE; Type 0: Not a Combination Product04/28/2015
    2NDC:63940-074-43532 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/05/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34705/05/2012
    Labeler - HARMON STORES, INC. (804085293)
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