5% Menthol Pain Relief Patch
FDA Label NDC 85323-006
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Xuzhou Lanting Pharmaceutical Co., Ltd for the product 5% Menthol Pain Relief Patch (NDC 85323-006). 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 5% menthol pain relief patch, package ndc code 85323-006-01, active ingredient, purpose, warnings, inactive ingredients, otc - keep out of reach of children, other information, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Active Ingredient: Menthol 5%
Purpose
Purpose: Topical anesthetic
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
- do not bandage tightly or use with a heating pad
- avoid contact with the eyes and mucous membranes
- do not apply to wounds or damaged skin.
- condition worsens
- symptoms persist for more than 7 days or clear up and occur again within a few day
- redness is present
- skin irritation develops
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
Other Information
- store at roo temperature 68 to 77℉ (20 to 25℃)
Directions
Directions
Adult and children 12 years of age and older:
- peel off protective backing and apply sticky side to affected area
- carefully remove backing from patch
- should be used to 8 hours
- ashould be used no more than 3 times a day
- Children under 12 years of age: consult a doctor
Uses
Uses
Temporarily relieves minor pains associated with:
- arthritis
- simple backache
- muscle strains
- bursitis
- tendonitis
- sprains
- bruises
- cramps
Indications & Usage
Temporarily relieves minor pains associated with:
- arthritis
- simple backache
- muscle strains
- bursitis
- tendonitis
- sprains
- bruises
- cramps
- peel off protective backing and apply sticky side to affected area
- carefully remove backing from patch
- should be used to 8 hours
- ashould be used no more than 3 times a day
- Children under 12 years of age: consult a doctor
Adult and Children 12 years of age and older:
* Please review the disclaimer below.
