Healthwise Menstrual Pain Relief Patch
FDA Label NDC 71101-947
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Veridian Healthcare for the product Healthwise Menstrual Pain Relief Patch (NDC 71101-947). 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 drug facts, active ingredients (in each patch), purpose, uses, warnings, otc - keep out of reach of children, when using this product, stop using and consult a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients (In Each Patch)
Menthol 10.0%
Purpose
Topical Analgesic
Uses
For temporary relief of minor aches and pains in lower back abdomen associated with cramps
Warnings
For external use only
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.
When Using This Product
- Use only as directed
- Rare cases of serious burns have been reported with products of this type
- Don't bandage tightly or use with heating pad
- Avoid contact with the eyes, mucous membranes
- Do not apply to wounds or damaged skin
- Do not use at the same time as other topical analgesics.
Stop Using And Consult 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
- You experience signs of skin injury, such as pain, swelling, or blistering where the product was applied.
If Pregnant Or Breastfeeding
as a health professional before use
Keep Out Of Reach Of Children
Do not use on infants. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away
Directions
Adults and children 12 years of age and over: Carefully remove backing from patch. Apply sticky side of patch to affected area. Wear one patch up to 8-12 hours. Repeat as necessary, but no more than 2 times daily. Properly discard patch after single use. children under 12 years of age consult a physician.
Other Information
Store at room temperature, not to exceed 80°F (27°C)
Inactive Ingredients
• adhesive plaster • eucalyptus oil
Questions?
Call 1-866-326-1313
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