Otc - Active Ingredient
Capsaicin .025%
Melt Pain Away Cream
FDA Label NDC 72683-003
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 Melt Pain Away (NDC 72683-003). 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
Topical Analgesic
Indications & Usage
Temporarily relieves minor aches and pains of muscles and joints associated with:
- arthritis
- simple backache
- strains
- sprains
- bruises
Warnings
Use only as directed.
For external use only.
Otc - When Using
When using this product:
- avoid contact with eyes
- do not apply to wounds or damaged skin
- do not bandage tightly
Otc - Stop Use
Stop use and ask doctor if:
- condition worsens
- symptoms persist for more than 7 days, or clear up and reoccur again with a few days
- redness is present
- irritation develops.
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 over 18 years:
- Apply to affected area. Massage into the painful area until thoroughly absorbed. Repeat as necessary but no more than 3 to 4
- Wash hands with soap and water after applying.
- Consult a doctor.
times daily.
Children 18 years and younger:
Storage And Handling
- Store in a cool, dry place.
- Keep away from excessive heat or flame.
- Tamper-evident for your protection. Use only if safety seal is intact
Inactive Ingredient
Water, Magnesium Chloride, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Cetearyl Alcohol, Butyrospermum Parkii (Shea) Butter, Dimethyl Sulfone (MSM), Sodium Lactate, Glyceryl Stearate Citrate, Cetyl Palmitate, Glycerin, Glyceryl Stearate, Polyglyceryl-3 Diisostearate, Pentylene Glycol, Undecane, Xanthan Gum, Magnesium Sulfate, Tridecane, Potassium Chloride, Sodium Chloride, Calcium Chloride, Tocopheryl Acetate (Vitamin E), Hydroxyacetophenone, Panthenol, Allantoin, Pentaerythrityl Tetra-Di-T-Butyl Hydroxyhydrocinnamate, Sodium Hydroxide, Cymbopogon Flexuosus (East-Indian Lemongrass) Oil* *Organic
Otc - Questions
888-819-6472; Monday–Friday, 9am–5pm CT
Report any serious side effects to number above.
* Please review the disclaimer below.
