Other
Drug Facts
Manufactured exclusively for
and distributed by:
Natural Pain Relief Agency Inc.
Phoenix, AZ 85086
Extra Strength Pain Reliever
FDA Label NDC 59092-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Hpi Health Products Inc. for the product Extra Strength Pain Reliever (NDC 59092-002). 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 other, otc - purpose, uses, warnings, when using this product, stop use and ask a doctor if, 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
| Active Ingredient | Purpose |
|---|---|
| Capsaicin 0.035% | Topical analgesic |
| Menthol 3% | Topical analgesic |
Uses
temporary relief of minor aches and pains of muscles and joints associated with:
- simple backache
- arthritis
- bruises
- strains
- sprains
Warnings
- For external use only.
When Using This Product
- use only as directed
- do not bandage
- do not use with a heating pad
- avoid contact with eyes and mucous membranes
- do not apply to wounds or damaged, broken or irritated skin
- a transient burning sensation may occur upon application but generally disappears in several days.
- if severe burning sensation occurs, discontinue use
- do not expose the area treated with product to heat or direct sunlight
- do not use if you are allergic to capsaicin or chili peppers
Stop Use And Ask A Doctor If
- condition worsens
- redness is present
- irritation develops
- 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 breast-feeding, ask a health care professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
adults and children over 18 years:
- apply to affected area
- massage into painful area until thoroughly absorbed
- repeat if necessary, but no more than 3 to 4 times daily
- WASH HANDS WITH SOAP AND WATER AFTER APPLYING
- children 18 years and younger: ask a doctor
Other Information
- store at 20-25° C (68-77° F)
Inactive Ingredients
carbomer, ethyl alcohol, germaben II, triethanolamine, water
Questions Or Comments?
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Principal Display Panel - 57 Ml Bottle Box
LaKOTA®
SOFT-TOUCH PAIN RELIEVER
Extra Strength
Pain Reliever
Capsaicin and Menthol -
Topical analgesic
57mL (2 fl oz)
Principal Display Panel (57 mL Bottle Box)
* Please review the disclaimer below.
