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  5. Label Information: Dirt Pain Relieving Gel

FDA Label for Dirt Pain Relieving Gel

View Indications, Usage & Precautions

Table of Contents

    1. DRUG FACTS
    2. ACTIVE INGREDIENTS:
    3. PURPOSE
    4. USES:
    5. WARNINGS:
    6. DO NOT USE
    7. WHEN USING THIS PRODUCT
    8. STOP USE AND ASK A DOCTOR IF
    9. KEEP OUT OF REACH OF CHILDREN.
    10. IF PREGNANT OR BREAST-FEEDING,
    11. DIRECTIONS:
    12. INACTIVE INGREDIENTS:
    13. PACKAGE LABELING:

Dirt Pain Relieving Gel Product Label

The following document was submitted to the FDA by the labeler of this product Purivitae, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Drug Facts




Active Ingredients:



Menthol 4%


Purpose



Topical Analgesic


Uses:



For the temporary relief of minor aches and pains of muscles and joints, associated with arthritis, simple back aches, strains, bruises, and sprains.


Warnings:



For external use only


Do Not Use



  • on damaged or brokin skin.

When Using This Product



  • Avoid contact with the eyes.
  • Do not bandage tightly.

Stop Use And Ask A Doctor If



  • condition worsens, or if symptoms persist for more than 7 days or 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


If Pregnant Or Breast-Feeding,



ask a health professional before use


Directions:



Adults and children over 12 years of age: 

  • apply generously to affected areas
  • rub into affected area until absorbed into the skin
  • repeat as necessary, but no more than 4 times daily

    • Children 12 years or younger: ask a doctor


Inactive Ingredients:



Activated Charcoal, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Calendula Officinalis Extract, Ethylhexylglycerin, Eucalyptus Globulus Oil, Glycerin, Ilex Paraguariensis (Yerba Mate') Extract, Melaleuca Alternifolia (Tea Tree) Oil, Methylsulfonylmethane (MSM), Phenoxyethanol, Polysorbate-20, Propylene Glycol, SD-Alcohol 40B, Tocopheryl Acetate (Vitamin E), Triethanolamine.


Package Labeling:



Label - Label

Label - Label


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