Karma Rub Elemental Pain Relief Lotion
FDA Label NDC 81155-104

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Elemental Bliss Llc for the product Karma Rub Elemental Pain Relief (NDC 81155-104). 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 active ingredients, purpose, uses:, warnings:, do not use, when using this product, stop use and ask a doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Lidocaine hydrochloride 1.5%

Purpose

Topical Analgesic

Uses:

For temporary relief of pain (and itching) associated with minor burns, sunburn, minor cuts, scrapes, insect bites, or minor skin irritations

Warnings:

For external use only

Do Not Use

- in large quantities, particularly over raw surfaces or blistered areas

When Using This Product

- avoid contact with the eyes

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

Other Information

  • 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: consult a doctor
    • Store at 20-25°C (68-77°F) and protect from moisture

Inactive Ingredients

Aloe Barbadensis Leaf Juice (Aloe Vera Gel) Aqua (Deionized Water, Cetearyl Alcohol, Cocos Nucifera (Coconut) Oil, Magnesium Chloride
Hexahydrate, Ethylhexylglycerin, Methylsulfonylmethane (MSM), Phenoxyethanol, Polysorbate-60, SteariAcid, Tocopheryl Acetate (Vitamin E), Urea

Questions

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