FDA Label for Overnight Relief Gel-patch
View Indications, Usage & Precautions
Overnight Relief Gel-patch Product Label
The following document was submitted to the FDA by the labeler of this product Shanghai Chuangshi Medical Technology (group) Co., Ltd.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient
Menthol 5% w/w ...... Purpose: Topical analgesic
Purpose
Topical analgesic
Uses
Temporarily relieves minor aches and pains of muscles and joints associated with:
- simple backache
- arthrits
- strains
- bruises
- sprains
Warnings
For external use only
When using this prudocts:
• use only as directed
• avoid contact with eyes or on mucous membranes
• do not apply to wounds or damaged skin
• do not apply to irritated skin or if excessive irritation develops
• do not bandage tightly or use with heating pad or device
Stop use and ask a doctor if:
• you experience pain, swelling or blistering of the skin
• condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days
• arthritic pain persists for more than 10 days, or redness is present
If pregnant or breastfeeding, ask a health professional before use.
Keep out of reach of children. If accidentally ingested, get medical help or contact a Poison Control Center immediately
Ask Doctor
Stop use and ask a doctor if:
• you experience pain, swelling or blistering of the skin
• condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days
• arthritic pain persists for more than 10 days, or redness is present
If pregnant or breastfeeding, ask a health professional before use.
When Using
When using this prudocts:
• use only as directed
• avoid contact with eyes or on mucous membranes
• do not apply to wounds or damaged skin
• do not apply to irritated skin or if excessive irritation develops
• do not bandage tightly or use with heating pad or device
Do Not Use
• do not apply to wounds or damaged skin
• do not apply to irritated skin or if excessive irritation develops
• do not bandage tightly or use with heating pad or device
Stop Use
Stop use and ask a doctor if: Burning disconfort or excessive skin irritation develops, condition worsens, or if symptoms persist for more than 7 days, or clear up and occur again within a few days
Pregnancy Or Breast Feeding
If pregnant or breastfeeding, ask a health professional before use.
Keep Out Of Reach Of Children
If accidentally ingested, get medical help or contact a Poison Control Center immediately
Directions
• adults and children 12 years of age and older: Clean and dry affected area, pop apart and partially peel back protective film and apply exposed gel-patch to site of pain. Carefully remove remaining film while pressing the gel-patch to skin and leave in place for up to 8 hours. Use on affected areas not more than 3 to 4 times daily.
• children under 12 years of age: consult a physician
• wash hands after use with cool water
Dosage Forms & Strengths
This is patch dosage form.
The active ingredient strength is 5%.
Inactive Ingredients
Water, Glycerin, Polyacrylic Acid, Propylene Glycol, Sodium Polyacrylate, Mineral Oil, Lavender Essential Oil, Polysorbate 80, PVP, Petrolatum, Dihydroxyaluminum Aminoacetate, Edetate Disodium, Kaolin, Carboxymethylcellulose Sodium, Titanium Dioxide, L-Tartaric Acid, Benzalkonium Chloride, Lauralkonium Chloride
Questions Or Comments
Questions or comments: 86-21-31166566
Other Information
• store at 20-25℃ (68-77℉)
• store in a cool dry place away from direct sunlight
Package Label. Principal Display Panel
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