Package Label.Principal Display Panel
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Silvera Pain Relief Patch
FDA Label NDC 69379-037
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Home Aide Diagnostics, Inc. for the product Silvera Pain Relief Patch (NDC 69379-037). 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 package label.principal display panel, otc - active ingredient, indications & usage, warnings, otc - stop use, otc - keep out of reach of children, otc - pregnancy or breast feeding, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
ACTIVE INGREDIENTS
- Capsaicin 0.0375% - Topical Analgesic
- Menthol 5% - External Analgestic
- Lidocaine 1% - Topical Analgesic
Indications & Usage
USES
- For relief of muscle aches and pains as well as:
- Arthritis
- Backaches
- Strains
- Sprains
Warnings
WARNINGS
- Do not get into eyes or on mucous membranes
- Do not apply to wounds, damaged or irritated skin
- Do not bandage or cover with any type of wrap except clothing
- Do not use with a heating pad or apply external heat
- Do not use in large quantities, particularly over raw surfaces or blistered areas
- This product may cause allergic reaction in some individuals
Otc - Stop Use
STOP USE AND ASK A DOCTOR IF
- Condition worsens
- Severe skin irritation occurs
- Pain persists for more than seven days
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
Otc - Pregnancy Or Breast Feeding
IF PREGNANT OR BREAST-FEEDING
- Ask a healthcare professional before use
Dosage & Administration
DIRECTIONS
- Store below 25 oC (77 oF). Avoid direct sunlight
- Clean and dry affected area
- Remove patch from backing and apply to affected area
- Use only one patch at a time and maximum of four patches daily
- Leave patch on affeted area for up to 8-hours
- Do not use patch for longer than 5 consecutive days unless directed by a physician
- Children under 12 years of age should consult a physician prior to use
Inactive Ingredient
INACTIVE INGREDIENTS
- Water
- Pvpk-90
- tartaric acid
- NP-700
- Aluminium hydroxide
- EDTA2Na
- Titanium dioxide
- Glycerin
- Pvpp
- Alcohol borneol
- Camphor
Otc - Purpose
- FOR EXTERNAL USE ONLY
- Use only as directed
* Please review the disclaimer below.
