Label: EARTHS CARE PAIN RELIEVING- camphor (natural), menthol and methyl salicylate ointment

  • NDC Code(s): 24286-1554-2
  • Packager: DLC Laboratories, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 07/13

If you are a consumer or patient please visit this version.

  • Active Ingredients

    Camphor 4%

    Menthol 10%

    Methyl Salicylate (Wintergreen Oil) 15%

    Purpose

    Topical Analgesic

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  • Uses

    Temporarily relieves the minor aches and pains of muscles and joints associated with:

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

    For external use only.

    Allergy Alert:If you are allergic to aspirin or salicylates, consult a doctor before use.

    Do not use

    • with a heating pad or other heat sources (may blister skin)
    • on children under 12 years of age
    • on wounds or damaged skin
    • if you are taking anticoagulant medication

    Ask a doctor before use

    if here is redness over the affected area.

    When using this product

    • avoid contact with the eyes and mucous membranes
    • do not bandage tightly

    Stop and ask a doctor if

    • skin redness or excessive irritation of the skin develops
    • symptoms clear up and occur again within a few days
    • condition worsens or if symptoms persist for more than 7 days

    Keep out of reach of children.

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

    If pregnant or breast-feeding,

    ask a health professional before use.

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  • Directions

    • use only as directed
    • adults and children 12 years of age and older:  apply to affected area not more than 3 or 4 times daily.
    • avoid overuse on large areas of the skin
    • wash hands thoroughly after application
    • children under 12 years of age: consult a doctor.
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  • Inactive Ingredients

    beeswax, Butyrospermum parkii (shea) butter, Prunus amygdalus dulcis (sweet almond) oil, Rosmarinus officinialis (rosemary) extract, tocopherol (natural vitamin E)

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  • Questions?

    call 1-888-602-6380

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  • SPL UNCLASSIFIED SECTION

    Origins

    Natural Camphor is found in the wood of the Camphor Laurel tree (Cinnamomum camphora), an evergreen species from Asia. Natural Menthol is a substance found in peppermint and in other mint oils. Natural Wintergreen Oil is extracted from the leaves of wintergreen plants such as the Eastern Teaberry (Gaultheria procumbens).

    Indications

    Earth's Care Pain Relieving Ointment is a powerful blend of three natural ingredients that provide soothing, penetrating relief from sore muscles, joint pain, backache and minor arthritis. Our proprietary formula features naturally-sourced Camphor, Menthol and Wintergreen Oil that together work as an effective analgesic without parabens or phthalates.

    • No Preservatives
    • No Animal Testing
    • No Artificial Colors or Fragrances
    • No Petrolatum

    Triple Action Formula:

    • Camphor
    • Menthol
    • Wintergreen Oil

    RETAIN CARTON FOR COMPLETE DRUG FACTS.

    Distributed by:
    Earth's Care Natural Products, Inc.
    Long Beach, California 90805 USA
    Questions: 1-888-602-6380

    earths-care.com

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  • PRINCIPAL DISPLAY PANEL - 71 g Jar Box

    EARTH'S
    CARE

    Allergy
    Tested

    PARABEN
    FREE

    TRIPLE ACTION

    Pain Relieving
    Ointment

    Relieves Minor Backache,
    Sprains, Muscle & Joint Pain

    1%
    FOR THE
    PLANET
    MEMBER

    2.5 OZ. (71 g)

    Principal Display Panel - 71 g Jar Box
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  • INGREDIENTS AND APPEARANCE
    EARTHS CARE PAIN RELIEVING 
    camphor, menthol, methyl salicylate ointment
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:24286-1554
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CAMPHOR (NATURAL) (CAMPHOR (NATURAL)) CAMPHOR (NATURAL) 4.0 g  in 100 g
    MENTHOL (MENTHOL) MENTHOL 10.0 g  in 100 g
    METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE 15.0 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    YELLOW WAX  
    ROSEMARY  
    SHEA BUTTER  
    ALMOND OIL  
    TOCOPHEROL  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:24286-1554-2 1 in 1 BOX
    1 71 g in 1 JAR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 11/29/2011
    Labeler - DLC Laboratories, Inc. (093351930)
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