Label: GOLD BOND MEDICATED CRACKED SKIN FILL AND PROTECT- petrolatum cream

  • 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 February 13, 2018

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

  • SPL UNCLASSIFIED SECTION

    Gold Bond Medicated Cracked Skin Fill & Protect

    Drug Facts

  • Active ingredient

    Petrolatum 30%

  • Purpose

    Skin protectant

  • Uses

    • temporarily protects minor:
      ? cuts
      ? scrapes
      ? burns
    • temporarily protects and helps relieve chapped or cracked skin
  • Warnings

    For external use only

    When using this product

    • avoid contact with eyes

    Stop use and ask a doctor if

    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

  • Directions

    • apply as needed.
  • Inactive ingredients

    water, glycerin, glyceryl stearate, dimethicone, steareth-21, distearyldimonium chloride, polyethylene, stearyl alcohol, cetearyl alcohol, behentrimonium methosulfate, hydrolyzed jojoba esters, jojoba esters, aloe barbadensis leaf juice, allantoin, butyrospermum parkii (shea) butter extract, ceramide NP, ceramide NS, ceramide EOS, ceramide EOP, ceramide AP, cocodimonium hydroxypropyl hydrolyzed rice protein, cetyl alcohol, biotin, cholesterol, caprooyl phytosphingosine, polysorbate 60, caprooyl sphingosine, bisabolol, 3-O-ethyl ascorbic acid, zingiber officinale (ginger) root extract, stearamidopropyl PG-dimonium chloride phosphate, butylene glycol, behenic acid, ceteareth-25, propylene glycol, ethylhexylglycerin, steareth-2, methylparaben, tocopheryl acetate, hydrolyzed collagen, EDTA, potassium hydroxide, caramel

    Please keep carton as it contains important information.

  • PRINCIPAL DISPLAY PANEL

    GOLD BOND
    CRACKED SKIN
    FILL & PROTECT
    SKIN PROTECTANT
    CREAM
    30% Petrolatum
    Net wt 0.75 oz (21 g)

    GOLD BOND
CRACKED SKIN
FILL & PROTECT
SKIN PROTECTANT
CREAM
30% Petrolatum
Net wt 0.75 oz (21 g)

  • INGREDIENTS AND APPEARANCE
    GOLD BOND MEDICATED CRACKED SKIN FILL AND PROTECT 
    petrolatum cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-0518
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM30 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    STEARETH-21 (UNII: 53J3F32P58)  
    DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    BEHENTRIMONIUM METHOSULFATE (UNII: 5SHP745C61)  
    HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ALLANTOIN (UNII: 344S277G0Z)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    CERAMIDE 2 (UNII: C04977SRJ5)  
    CERAMIDE EOS (UNII: CR0J8RN66K)  
    CERAMIDE 1 (UNII: 5THT33P7X7)  
    CERAMIDE 6 II (UNII: F1X8L2B00J)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    BIOTIN (UNII: 6SO6U10H04)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    N-HEXANOYLSPHINGOSINE (UNII: 038753E78J)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    3-O-ETHYL ASCORBIC ACID (UNII: 6MW60CB71P)  
    GINGER (UNII: C5529G5JPQ)  
    STEARAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: W6000VEI5Y)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    BEHENIC ACID (UNII: H390488X0A)  
    CETEARETH-25 (UNII: 8FA93U5T67)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    STEARETH-2 (UNII: V56DFE46J5)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    HYDROGENATED JOJOBA OIL/JOJOBA OIL, RANDOMIZED (IODINE VALUE 64-70) (UNII: 96YYQ5TK1K)  
    EDETIC ACID (UNII: 9G34HU7RV0)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    CARAMEL (UNII: T9D99G2B1R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41167-0518-11 in 1 CARTON02/13/2018
    121 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34702/13/2018
    Labeler - Chattem, Inc. (003336013)