Label: DRAGON PAIN RELIEVING- camphor, menthol lotion

  • NDC Code(s): 83552-120-00
  • 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 eyes
    • do not bandage tightly

    Stop use and ask doctor if

    • symptoms perists 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

    Lotion Base (Water, Sunflower Seed Oil, Isopropyl Palmitate, Stearic Acid, Stearyl Alcohol, Aloe Leaf Juice, Shea Butter, Olea Europaea Olive Fruit Oil, Titanium Dioxide, Tocopheryl Acetate, Chamomilla Recutita Matricaria Flower Extract, Sodium Hydroxide, Glyceryl Stearate, Phenoxyethanol, Petrolatum, PEG-100 Stearate, Carbomer, Glycerin, Ethylhexylglycerin, Tocopherol) Cajeput Oil, Cassia Oil, Clove Oil, Hemp Extracted Oil, Peppermint Oil, Polysorbate 20

  • Questions?

    888.442-2702 Monday-Friday, 8am-5pm PST or visit us at www.americannawellness.com

  • PRINCIPAL DISPLAY PANEL

    AMERICANNA WELLNESS

    XTRA STRENGTH

    DRAGON PAIN RELIEVING LOTION

    BROAD SPECTRUM

    Menthol 11%

    Camphor 10%

    5000mg CBD

    375mg CBN

    375mg CBG

    NET WT 16.9oz (479g)

    1

  • INGREDIENTS AND APPEARANCE
    DRAGON PAIN RELIEVING 
    camphor, menthol lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83552-120
    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
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    MATRICARIA CHAMOMILLA FLOWERING TOP (UNII: 3VNC7T6Z02)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CAJUPUT OIL (UNII: J3TO6BUQ37)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    SUNFLOWER SEED (UNII: R9N3379M4Z)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    CLOVE OIL (UNII: 578389D6D0)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    CHINESE CINNAMON OIL (UNII: A4WO0626T5)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83552-120-00479 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product12/21/2023
    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(83552-120)
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