Label: DRAGON PAIN RELIEVING BALM- camphor, menthol salve

  • NDC Code(s): 83552-102-00
  • Packager: Americanna Wellness, Inc.
  • 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 July 10, 2023

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  • Active Ingredients

    Camphor 3.1%

    Menthol 5.3%

  • Purpose

    Camphor 3.1%.................Topical Analgesic

    Menthol 5.3%..................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

    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?

    888.442.2707 Monday-Friday, 8am-5pm PST or visit us at www.americannawellness.com

  • PRINCIPAL DISPLAY PANEL

    Regular Strength

    DRAGON Pain Relieving Balm

    Broad Spectrum

    Menthol 5.3% | Camphor 3.1%

    300mg CBD | 20mg CBN | 2mg CBG

    Net Wt 2oz (59mL)

    1

    2

  • INGREDIENTS AND APPEARANCE
    DRAGON PAIN RELIEVING BALM 
    camphor, menthol salve
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83552-102
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)3.1 g  in 100 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5.3 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CLOVE OIL (UNII: 578389D6D0)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    PEPPERMINT (UNII: V95R5KMY2B)  
    CAJUPUT OIL (UNII: J3TO6BUQ37)  
    CHINESE CINNAMON OIL (UNII: A4WO0626T5)  
    HEMP (UNII: TD1MUT01Q7)  
    CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83552-102-001 in 1 CARTON07/10/2023
    156.7 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 finalpart34807/10/2023
    Labeler - Americanna Wellness, Inc. (118975729)
    Establishment
    NameAddressID/FEIBusiness Operations
    Americanna Wellness, Inc.118975729manufacture(83552-102)
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