Real Time Pain Relief Sports Cream
FDA Label NDC 58133-700

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cosmetic Specialty Labs, Inc. for the product Real Time Pain Relief Sports Cream (NDC 58133-700). 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 ingredient, purpose, keep out of reach of children, uses, warnings, when using this product, stop using and ask a doctor if, if pregnant or breast-feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Menthol 0.5%

Purpose

Topical analgesic

Keep Out Of Reach Of Children

If swallowed, get medical help or contact a poison control center right away.

Uses

Temporarily relieves minor pain associated with

  • arthritis
  • simple backache
  • muscle strains
  • sprains
  • bruises

Warnings

for external use only

When Using This Product

  • use only as directed
  • avoid contact with eyes or mucus membranes
  • do not apply to wounds or damaged skin
  • do not bandage tightly

Stop Using And Ask A Doctor If

  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days
  • redness is present
  • irritation develops

If Pregnant Or Breast-Feeding

ask a health professional before use

Directions

Adults And Children Over 2 Years

  • apply generously to affected area
  • massage into painful area until throughly absorbed into skin
  • repeat as necessary, but no more than 4 times daily

    • children 2 years or younger: ask a doctor

Children 12 Years Or Younger

ask a doctor

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Anthemis nobilis (Roman Chamomile), Arnica Montana Flower Extract, Butylene Glycol, Calendula officianlis (Marigold), Caprylyl Glycol, Carbomer, Centaurea cyanus (Cornflower), Cetearyl Alcohol, Cetyl Alcohol, Chamomilla Recutita (Matricaria Chamomilla), Coriandrum Sativum (Coriander) Fruit Oil, Curcuma Longa (Turmeric) Extract, Cupressus sempervirens (Cypress) Fruit Extract, Emu Oil, Fragrance, Gaultheria procumbens (Wintergreen) Oil, Glycerin, Hamamelis Virginiana (Witch Hazel) Bark/Leaf/Twig Extract, Helichrysum Italicum Flower, Hypericum perforatum (St. John’s Wort), Jasminum Officianale (Jasmine) Flower Extract, Lavendula Angustifolia (Lavender) Oil, Magnesium Chloride, Methylsulfonylmethane, Myristica Fragrans (Nutmeg) Extract, Origanum Majorana (Marjoram) Leaf Extract, Phenoxyethanol, Purified Water, Rosmarinus Officinalis (Rosemary) Leaf Extract, Salix Alba (Willow) Bark Extract, SD Alcohol 40, Sorbitol, Tetrasodium EDTA, Tilia cordata (Lime Tree), Triethanolamine.

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