Active Ingredients
Capsaicin .025%
Spraypain Away
FDA Label NDC 75249-006
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Soliteint Kozmetikum Gyarto Es Forgalmazo, Termelo Es Kereskedelmi Korlatolt Felelossegu Tarsasag for the product Spraypain Away (NDC 75249-006). 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 ingredients, purpose, uses, 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
Purpose
Capsaicin .025%.............Topical Analgesic
Uses
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 within a few days
- redness is present
- irritation develops.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast feeding, 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 a Poison Control Center immediately.
Directions
Adults 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 times daily.
- Wash hands with soap and water after applying.
- Consult a doctor.
Children 18 years and younger:
Other Information
- 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 Ingredients
Water, Magnesium Chloride, Polysorbate 20, Caprylic/Capric Triglyceride
Questions Or Comments?
888-819-6472; Monday-Friday, 9am-5pm CT; Report any serious side effects to number above.
Package Label.Principal Display Panel
NDC:
72683-006-01
Asutra*
Spray
pain
away
Capsaicin .025%
Pain Relieving Spray
Refreshing Magnesium Oil
4 fl. oz. | 118 ml.
Paraben Free
Animal Test-Free PETA Vegan
1 (Spray Pain Away 125x95mm Fda 07 23 Print Page 001)
* Please review the disclaimer below.
