Label: ALLANTOIN- medicinal massage oil oil

  • NDC Code(s): 82876-438-34
  • Packager: Carolina Cannabis Creations L.L.C
  • 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 September 6, 2023

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  • Active ingredients

    Allantoin......1%

    Purpose

    Skin protectant

  • Uses

    Helps prevent and temporarily protect and help relieve chafed, chapped, or cracked skin.

    Helps prevent and protect from the drying of wind and cold weather

  • Warnings

    For external use only.

  • Do not use

    on deep or puncture wounds, animal bites, serious burns

  • When using this product

    Do not get into eyes

    Stop use and ask doctor if

    condition worsens, symptoms last for more than 7 days, condition clears up but occurs again within a few days, rash or irritation occurs

    Stop use and ask doctor if

    Condition worsens, Symptoms last for more than 7 days, condition clears up but occurs again in a few days, rash or irritation occurs

  • If pregnant or breast feeding

    Consult a health professional before use.

    in case of overdose

    seek medical help or contact a poison control center right away

  • Directions

    shake well before use.

    adults and children 2 years and over; apply as needed.

    children under 2 years; consult a doctor

    keep out of reach of children

    Keep out of reach of children

  • Other information

    Store at 68-77 degrees F (20-25 degrees C), avoid direct sunlight

  • inactive ingredients

    Arnica montana, Cannabidiol, Jojoba oil, Lavender oil, Peppermint oil, Rice bran oil, Sweet almond oil.

  • PRINCIPAL DISPLAY PANEL

    bottle label

  • INGREDIENTS AND APPEARANCE
    ALLANTOIN 
    medicinal massage oil oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82876-438
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN1 g  in 108.48 g
    Inactive Ingredients
    Ingredient NameStrength
    RICE BRAN OIL (UNII: LZO6K1506A) 65.29 g  in 108.48 g
    LAVENDER OIL (UNII: ZBP1YXW0H8) 0.28 g  in 108.48 g
    PEPPERMINT OIL (UNII: AV092KU4JH) 0.15 g  in 108.48 g
    ARNICA MONTANA FLOWER WATER (UNII: U7L2JP51PR) 2.85 g  in 108.48 g
    ALMOND OIL (UNII: 66YXD4DKO9) 27.2 g  in 108.48 g
    JOJOBA OIL (UNII: 724GKU717M) 10.58 g  in 108.48 g
    CANNABIDIOL (UNII: 19GBJ60SN5) 1.13 g  in 108.48 g
    Product Characteristics
    ColoryellowScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82876-438-34108.48 g in 1 BOTTLE; Type 0: Not a Combination Product09/06/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM01609/06/2022
    Labeler - Carolina Cannabis Creations L.L.C (118697474)
    Establishment
    NameAddressID/FEIBusiness Operations
    Carolina Cannabis Creations L.L.C118697474manufacture(82876-438)
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