Otc - Active Ingredient
ACTIVEINGREDIENTS
PURPOSE
CamphorMenthol
3.1%
Topical analgesicTopical analgesicTopical analgesic
6.0%
Methyl salicylate 10.0%
Drmitsui Pain Relieving Patch
FDA Label NDC 85713-101
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Guangzhou Ruyu Cosmetics Co., Ltd for the product Drmitsui Pain Relieving Patch (NDC 85713-101). 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 otc - active ingredient, otc - purpose, inactive ingredient, warnings, dosage & administration, indications & usage, otc - keep out of reach of children, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
For temporary relief of minor aches & pains of muscles & joints associated with:Arthritis, Simple backache, Strains, Bruises, Sprains
Inactive Ingredient
MINERAL OIL, PERFUME,POLYISOBUTYLENE, STYRENE-ISOPRENE-STYRENE BLOCK COPOLYMER.
SYNTHETIC ALUMINUM SILICATE,TERPENE RESIN, TITANIUM DIOXIDE.
Warnings
1.For external use only.
2.Allergy alert: lf prone to allergic reaction from aspirin or salicylates, consult a doctor before use3.Do not use: On wounds or damaged skin. With a heating pad. lf you are allergic to anyingredients of this product.
4.When using this product: Use only as directed. Avoid contact with the eyes. mucousmembranes or rashes. Do not bandage tightly
5.Stop using it and ask a doctor if: Skin reactions such as redness, itching, rash, excessiveirritation, burning sensation,swelling or blistering occur. Conditions worsen.Symptomspersist for more than 7 days. Symptoms clear up and occur again within a few days6.Pregnancy/breast-feeding warning: lf pregnant or breast-feeding, ask a healthprofessional before use.
Dosage & Administration
Apply to affected areas not morethan 3 to 4 times daily.
Remove patch from the skin after at most 8-hour application.
Indications & Usage
DIRECTIONS
Adults and children 12 years of age and over:1. Clean and dry affected area. 2. Remove patch from film. 3. Apply to affected areas not morethan 3 to 4 times daily. 4. Remove patch from the skin after at most 8-hour application.
Otc - Keep Out Of Reach Of Children
Keep out of children to reach
Package Label.Principal Display Panel
Labeling (Labeling 101 01)
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