Otc - Active Ingredient
Menthol USP 4%
Ease Your Pain Cream
FDA Label NDC 72683-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Proximity Capital Partners Llc Dba Asutra for the product Ease Your Pain (NDC 72683-002). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - when using, otc - stop use, otc - pregnancy or breast feeding, otc - 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
Otc - Purpose
Menthol USP 4% ........................... Topical Analgesic
Indications & Usage
For the temporary relief of minor aches and pains of muscles and joints associated with
- simple backache
- arthritis
- strains
- bruises
- sprains
Warnings
Use only as directed.
For external use only. Keep away from excessive heat or flame.
Otc - When Using
When using this product:
- Avoid contact with eyse and mucous membranes
- Do not apply to wounds or damaged skin
- Do not bandage or use with a heating pad, other ointments, creams, sprays, or liniments
Otc - Stop Use
Stop use and ask doctor if:
- Condition worsens
- Symptoms persist for more than 7 days, or clear up and occur again within a few days
Otc - Pregnancy Or Breast Feeding
If pregnant or breastfeeding: Ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If accidentally ingested, get medical help or contact Poison Control Center immediately.
Dosage & Administration
Adults and children 2 years of age and older:
- Apply to affected area not more than 3 to 4 times daily.
- Consult physician.
Children under 2 years of age:
Storage And Handling
- Store in a cool, dry place.
- Avoid direct sunlight.
- Tamper-evident for your protection. Use only if safety seal is intact.
- Keep away from excessive heat or flame.
Inactive Ingredient
Aloe Vera Leaf Extract (BiAloe(R)), Arnica Montana, Calendula Officinalis Flower Extract, Carbomer, Citric Acid, Dimethyl Sulfone (MSM), Emu Oil, Ethyl Alcohol, Metyhl GLucose Dioleate, Potassium Sorbate, Purified Water, Sodium Hydroxide
Otc - Questions
888-819-6472
Monday - Friday, 9am - 5pm CT
Report any serious side effects to number above.
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