Label: ABONIKI BALM - TOPICAL PAIN RELIEF BALM- camphor, eucalyptus, menthol, methyl salicylate cream

  • NDC Code(s): 82729-001-01, 82729-001-02
  • Packager: J C UDEOZOR & SONS GLOBAL INDUSTRIES LTD
  • 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 December 26, 2022

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  • Aboniki® Balm - Topical Pain Relief Balm

  • Drug Facts

    Drug Facts

  • Active Ingredients

    Active Ingredients (In each gram)

    Camphor 5.04%

    Eucalyptus Oil 2.30%

    Menthol 5.10%

    Methyl Salicylate 4.25%

  • Purpose

    Active Ingredients (In each gram) Purpose
    Camphor 5.04%External Analgesic
    Eucalyptus Oil 2.30%External Analgesic
    Menthol 5.10%External Analgesic
    Methyl Salicylate 4.25%External Analgesic
  • USES

    Temporarily relieves minor aches & pains related to:

    • arthritis
    • simple backaches
    • sore muscles
    • joint pain
    • dislocation
    • leg cramps
    • bruises
    • sprains
    • lumbago
  • Warning

    For external use only.

  • Do not use

    • on wounds or damaged skin
    • with a heating pad
    • if you are allergic to any of the ingredients
  • Ask a doctor or pharmacist before use if you have

    • sensitive skin
    • redness over the affected area
  • When using this product

    • avoid contact with eyes and mucous membranes
    • do not bandage tightly
  • Stop use and ask a doctor if

    • rash, itching, or excessive irritation of the skin develops
    • condition worsens or symptoms persist for more than 7 days
    • symptoms clear up and occur again within a few days
  • Keep out of reach of children.

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

  • Direction

    • Use only as directed
    • For adults and children over 12 years, apply to the affected area 3 to 4 times daily
    • Wash hands after use
    • For Children under 12 years, consult a doctor before use
  • Other Information

    • Store in a cool, dry place between 20 oC to 25 oC (68 oF - 77 oF)
    • Do not use if the seal is broken
    • See cap for lot no, mfg, and exp date
  • Inactive Ingredients

    FD&C Yellow No.6, Lanolin, Paraffin, White Petrolatum.

  • Contact Info

    Distributed by:

    J. C. Udeozor & Sons Global Industries Limited

    Email:

    Info-US@aboniki.com

    Mail:

    300 Delaware Ave, Suite 210 #465
    Wilmington, DE 19801

    USA

  • Aboniki ® Balm - Topical Pain Relief Balm - Twin Pack [Two 25g (0.88 OZ) Jar Inside]

    • New Look
    • Same Powerful Formula
    • Fast and Deep Penetrating Pain Relief

    Aboniki Balm 2 Pack

  • INGREDIENTS AND APPEARANCE
    ABONIKI BALM - TOPICAL PAIN RELIEF BALM 
    camphor, eucalyptus, menthol, methyl salicylate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82729-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662) EUCALYPTUS OIL23 mg  in 1 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL51 mg  in 1 g
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE42.5 mg  in 1 g
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)50.4 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    WHITE PETROLATUM (UNII: B6E5W8RQJ4)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    LANOLIN (UNII: 7EV65EAW6H)  
    Product Characteristics
    ColoryellowScore    
    ShapeSize
    FlavorMENTHOLImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82729-001-0125 g in 1 JAR; Type 0: Not a Combination Product06/01/2022
    2NDC:82729-001-022 in 1 CARTON06/01/2022
    2NDC:82729-001-0125 g in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34806/01/2022
    Labeler - J C UDEOZOR & SONS GLOBAL INDUSTRIES LTD (851768299)
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