Label: GOLD BOND ULTIMATE DIABETICS- dimethicone and petrolatum cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 04/13

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  • SPL UNCLASSIFIED SECTION

    Drug Facts – Gold Bond Ultimate Diabetics’ Dry Skin Relief Foot Cream

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  • Active ingredients

    Dimethicone 3%
    White petrolatum 30%

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  • Purpose

    Skin protectant

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  • Uses

    • helps relieve, prevent and temporarily protect chafed, chapped, cracked or windburned skin
    • temporarily protects minor burns, cuts, and scrapes
    • helps protect from the drying effects of wind and cold weather
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  • Warnings

    For external use only

    When using this product

    • avoid contact with eyes

    Stop use and ask a doctor if

    • condition worsens
    • symptoms persist for more than 7 days or clear up and occur again within a few days

    Do not use on

    • deep or puncture wounds
    • animal bites
    • serious burns

    Keep out of reach of children.

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

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  • Directions

    • apply generously to affected area as needed
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  • Inactive ingredients

    water, glycerin, glyceryl stearate, distearyldimonium chloride, aloe barbadensis leaf juice, polyethylene, stearyl alcohol, cetearyl alcohol, methyl gluceth-20, behentrimonium methosulfate, steareth-21, steareth-2, allantoin, cocodimonium hydroxypropyl hydrolyzed rice protein, cetyl alcohol, tocopheryl acetate, butyrospermum parkii (shea) butter extract, PEG-10 rapeseed sterol, polysorbate 60, ceramide 2, hydrolyzed collagen, stearamidopropyl PG-dimonium chloride phosphate, jojoba esters, DMDM hydantoin, magnesium ascorbyl phosphate, butylenes glycol, methylparaben, palmitoyl oligopeptide, propylene glycol, hydrolyzed jojoba esters, propylparaben, EDTA, potassium hydroxide, tribehenin, C12-15 alkyl benzoate, retinyl palmitate (309-007)

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  • PRINCIPAL DISPLAY PANEL

    Gold Bond Ultimate
    Skin Protectant Foot Cream
    diabetics’
    Dry Skin Relief
    Net wt 3.4 oz (96 g)

    Gold Bond Ultimate
Skin Protectant Foot Cream
diabetics’ 
Dry Skin Relief
Net wt 3.4 oz (96 g)

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  • INGREDIENTS AND APPEARANCE
    GOLD BOND ULTIMATE DIABETICS 
    dimethicone and white petrolatum cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:41167-0540
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DIMETHICONE (DIMETHICONE) DIMETHICONE 0.03 g  in 1 g
    PETROLATUM (PETROLATUM) PETROLATUM 0.3 g  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    GLYCERIN  
    GLYCERYL MONOSTEARATE  
    DISTEARYLDIMONIUM CHLORIDE  
    ALOE VERA LEAF  
    STEARYL ALCOHOL  
    CETOSTEARYL ALCOHOL  
    METHYL GLUCETH-20  
    BEHENTRIMONIUM METHOSULFATE  
    STEARETH-21  
    STEARETH-2  
    ALLANTOIN  
    CETYL ALCOHOL  
    .ALPHA.-TOCOPHEROL ACETATE  
    SHEA BUTTER  
    PEG-10 RAPESEED STEROL  
    POLYSORBATE 60  
    CERAMIDE 2  
    STEARAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE  
    DMDM HYDANTOIN  
    MAGNESIUM ASCORBYL PHOSPHATE  
    METHYLPARABEN  
    PALMITOYL OLIGOPEPTIDE  
    PROPYLENE GLYCOL  
    HYDROLYZED JOJOBA ESTERS (ACID FORM)  
    PROPYLPARABEN  
    EDETIC ACID  
    POTASSIUM HYDROXIDE  
    TRIBEHENIN  
    ALKYL (C12-15) BENZOATE  
    VITAMIN A PALMITATE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:41167-0540-0 1 in 1 CARTON
    1 96 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part347 02/03/1998
    Labeler - Chattem, Inc. (003336013)
    Establishment
    Name Address ID/FEI Business Operations
    Chattem Plant 2 830410721 ANALYSIS(41167-0540), LABEL(41167-0540), MANUFACTURE(41167-0540), PACK(41167-0540), RECOVERY(41167-0540), RELABEL(41167-0540), REPACK(41167-0540)
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