Kalaya Extra Strength Pain Relief Cream With Hemp Seed Oil Cream
FDA Label NDC 43493-0013

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Avaria Health & Beauty Corp for the product Kalaya Extra Strength Pain Relief Cream With Hemp Seed Oil (NDC 43493-0013). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding drug facts, active ingredients, purpose, uses, warnings, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredients

Camphor 4%
Menthol 4%
Methyl salicylate 11%

Purpose

Topical Analgesic

Uses

Penetrating pain relief for the temporary relief of minor aches and pains of muscle and joint pain associated with arthritis, backache, strains, sprains and bruises.

Warnings

For external use only


Do not use

  • on wounds or damaged skin
  • with a heating pad
  • on children under 12 years of age with arthritis-like conditions

    • When using this product

    • avoid contact with eyes or mucous membranes
    • do not bandage tightly

      • Stop use and ask a doctor

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

        • Keep out of reach of children.

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

Directions

Adults and children 12 years and over. Use no more than 3-4 times daily. Apply cream to affected areas and thoroughly massage until penetrated. Wash hands with soap and water after use.

Other Information

• Store at 59°F - 77°F

• If seal is broken, do not use

Inactive Ingredients

Alcohol Denat., Arnica Montana Flower Extract, Carbomer, Ceteth-10 Phosphate, Dicetyl Phosphate, Eucalyptus Globulus Leaf Oil, Cetearyl Alcohol, Hemp Seed Oil, Ethylhexylglycerin, Phenoxyethanol, Glycerin, Isopropyl Palmitate, Methylsulfonylmethane, Oryza Sativa (Rice) Bran Oil, Sodium Hydroxide, Water

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Product Label

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