Label: ROCCOS OLD SCHOOL HEALING BALM- zinc oxide cream

  • 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 February 17, 2011

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  • Active Ingredient: Purpose:

    Zince Oxide 3%................................Skin Prorectant
  • Use:

    • To promote healing of minor skin irritations and sunburn.
  • Warnings:

    For external use only-skin. Flammable. Keep away from heat and flame.
  • When using this product

    • Avoid contact with the eyes. In case of contact with eyes, flush thoroughly with water.
  • Stop use and ask a doctor if

    condition worses or does not improve.

  • Keep out of reach of children.

    In case of accidental ingestion, seek professional assistance or contact a Poison Control Center Immediately.

  • Directions

    • Apply balm liberally as often as necessary.
  • Other information

    • Store at controlled room temperature.
    • Do not store above 105°F.


  • Inactive ingredients

    Mangifera Indica (Mango) Seed Butter, Cocos Nucifera (Coconut) Oil, Butyrospermum Parkii (Shea Butter) Fruit, Beeswax, Agave Americana Leaf Extract, Simmondsia Chinensis (Jojoba) Seed Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Cannibis Sativia (Hemp) Seed Oil, Persea Gratissima (Avocado) Oil, Caprylic/Capric Triglyceride (and) Gylceryl Isostearate (and) Polyhydroxystearic Acid, and Natural Fragrance

  • Questions?

    661-877-4280

  • PRINCIPAL DISPLAY PANEL

    Placeholder Text


    Roccos_Healing_Balm_30mL_label

  • INGREDIENTS AND APPEARANCE
    ROCCOS OLD SCHOOL  HEALING BALM
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24488-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE.9 mL  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    SHEANUT (UNII: 84H6HBP32L)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    AGAVE AMERICANA LEAF (UNII: 8511ZMP5QK)  
    JOJOBA OIL (UNII: 724GKU717M)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    COCONUT (UNII: 3RT3536DHY)  
    LIME (UNII: C7X2M0VVNH)  
    VERBENA HASTATA ROOT (UNII: LJ96XN173E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24488-010-1030 mL in 1 CANISTER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34802/17/2011
    Labeler - Roccos Old School (961956229)
    Registrant - Creations Garden Natural Products Inc. (961956229)
    Establishment
    NameAddressID/FEIBusiness Operations
    Creations Garden Natural Products Inc.961956229manufacture
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