Active Ingredient
Menthol 1.25%
Real Time Pain Relief Cream
FDA Label NDC 58133-600
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 Cream (NDC 58133-600). 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, uses, warnings, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding,, 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
Purpose
Topical Analgesic
Uses
temporarily relieves minor pain associated with:
- arthritis
- simple backache
- muscle strains
- sprains
- bruises
- cramps
Warnings
for external use only
When Using This Product
- use only as directed
- avoid contact with eyes or mucous membranes
- do not apply to wounds or damaged skin
- do not bandage tightly
Stop Use 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
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Directions:
adults and children over 2 years:
- apply generously to affected area
- massage into painful area until thoroughly absorbed into skin
- repeat as necessary, but no more than 4 times daily
children 2 years or younger: ask a doctor
Inactive Ingredients:
Aloe Barbadensis Leaf, Anthemis nobilis Extract, Arnica Montana Flower Extract, Butylene Glycol, Calendula officianlis Extract, Caprylyl Glycol, Capsicum Frutescens Fruit, Carbomer, Centaurea cyanus Extract, Cetearyl Alcohol, Cetyl Alcohol, Coriandrum Sativum (Coriander) Fruit Oil, Diazolidinyl Urea, Emu Oil, Fragrance, Glucosamine HCI, Hamamelis Virginiana (Witch Hazel) Bark/Leaf/Twig Extract, Hypericum perforatum Extract, Matricaria chamomilla Extract, Methylsulfonylmethane, Phenoxyethanol, Purified Water, Salix Alba (Willow) Bark Extract, SD Alcohol 40, Sodium Chondroitin Sulfate, Sorbitol, Tilia cordata Extract, Triethanolamine.
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