Active Ingredient
Menthol 5.1%
Camphor 5.1 %
Soltice Cream
FDA Label NDC 45728-100
10 label sections · Submitted to the FDA by Oakhurst Company · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Oakhurst Company for the product Soltice (NDC 45728-100). 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, do not use, when using this product, stop use and ask 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
Purpose
Topical Analgesic
Topical Analgesic
Uses
temporarily relieves minor aches and pains of muscle and joints associated with
- simple backache
- arthritis
- strains
- bruises
- sprains
Warnings
For external use only
Do Not Use
- on irritated skin
- on reddened skin
- on wounds
- on damaged skin.
When Using This Product
- avoid contact with eyes and mucous membranes (such as the inside of nose or mouth)
- do not bandage tightly.
Stop Use And Ask Doctor If
- condition worsens
- condition does not improve in 7 days
- condition clears up and occurs again within a few days
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away
Directions:
Rub into skin until Soltice is absorbed and disappears
Adults and children 2 years of age and over
apply to affected area not more than 3 to 4 times daily
Children under 2 years of age: ask a doctor
Inactive Ingredients
eucalyptus oil, glycerin, methyl salicylate, oleic acid, potassium hydroxide, stearic acid, water
* Please review the disclaimer below.
