Label: DRAGON PAIN RELIEVING BALM- camphor, menthol salve

  • NDC Code(s): 83552-116-00
  • Packager: AMERICANNA WELLNESS, INC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 21, 2023

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  • Active ingredients

    Camphor 10%

    Menthol 11%

  • Purpose

    Camphor 10%.................Topical Analgesic

    Menthol 11%...................Topical Analgesic

  • Uses

    For the temporary relief of minor aches and pains of muscles and joints associated with

    • simple backache
    • arthritis
    • strains
    • bruises
    • sprains
  • Warnings

    For external use only

    Do not use

    • on wounds or damaged skin

    When using this product

    • avoid contact with the eyes
    • do not bandage tightly

    When using this product

    • avoid contact with the eyes
    • do not bandage tightly

    Stop use and ask doctor if

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

    If pregnant or breastfeeding, ask a health professional before use.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.
    • Children under 2 years of age: do not use, consult a doctor.

  • Other information

    • store in a cool, dry place away from light
  • Inactive ingredients

    almond oil, beeswax, cajaput oil, cassia oil, clove oil, cocoa butter, coconut oil, grapeseed oil, hemp extract, hempseed oil, peppermint

  • Questions?

    888.444.2702 Monday-Friday, 8am-5pm PST or visit us at www.americannawellness.com

  • PRINCIPAL DISPLAY PANEL

    XTRA STRENGTH

    DRAGON

    PAIN RELIEVING BALM

    FULL SPECTRUM

    Menthol 11%

    Camphor 10%

    500mg CBD

    30mg CBN

    30mg CBG

    <.3% THC

    NET WT. 3.4oz (96.4g)

    1

    2

  • INGREDIENTS AND APPEARANCE
    DRAGON PAIN RELIEVING BALM 
    camphor, menthol salve
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83552-116
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)10 g  in 100 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL11 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CHINESE CINNAMON OIL (UNII: A4WO0626T5)  
    CLOVE OIL (UNII: 578389D6D0)  
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    CAJUPUT OIL (UNII: J3TO6BUQ37)  
    CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    HEMP (UNII: TD1MUT01Q7)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83552-116-001 in 1 CARTON12/21/2023
    196.4 g in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01712/21/2023
    Labeler - AMERICANNA WELLNESS, INC. (118975729)
    Establishment
    NameAddressID/FEIBusiness Operations
    AMERICANNA WELLNESS, INC.118975729manufacture(83552-116)
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