5% Menthol Pain Relief Patch, Package Ndc Code 85323-004-00
5% Menthol Pain Relief Patch, Package NDC Code 85323-004-00
5% Menthol Pain Relief Patch
FDA Label NDC 85323-004
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Xuzhou Lanting Pharmaceutical Co., Ltd for the product 5% Menthol Pain Relief Patch (NDC 85323-004). 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 5% menthol pain relief patch, package ndc code 85323-004-00, active ingredient, purpose, warnings, inactive ingredients, otc - keep out of reach of children, other information, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Purpose
Warnings
Warnings (For external use only)
- Do not use
- more than 1 patch at a time
- on wounds or damaged skin
- with a heating pad
- if you are allergic to any ingredients of this product
- use only as directed
- avoid contact with the eyes, mucous membranes or rashes
- do not bandage tightly
- 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
When using this product
Stop use and ask a doctor if
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Inactive Ingredients
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.
Other Information
- Avoid storing product in direct sunlight
- Protect product from excessive moisture
Dosage & Administration
Adult and children 12 years of age and over:
clean and dry affected area
remove film from patch and apply to the skin (see illustration)
apply 1 patch at a time to affected area, not more than 3 to 4 times daily
remove patch from the skin after at most 8-hour application
Children under 12 years of age: consult a doctor
Uses
Temporarily relieves minor pains associated with:
arthritis
simple backache
bursitis
tendonitis
muscle strains
sprains
bruises
cramps
Directions
Uses For temporary relieves minor pains associated with:
arthritis
simple backache
bursitis
tendonitis
muscle strains
sprains
bruises
cramps
Adult and children 12 years of age and over:
clean and dry affected area
remove film from patch and apply to the skin (see illustration)
apply 1 patch at a time to affected area, not more than 3 to 4 times daily
remove patch from the skin after at most 8-hour application
Children under 12 years of age: consult a doctor
* Please review the disclaimer below.
