Otc - Active Ingredient
Active ingredients
Lidocaine 4%
Assured Pain Relief
FDA Label NDC 69159-101
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Foshan Aqua Gel Biotech Co., Ltd., for the product Assured Pain Relief (NDC 69159-101). 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, indications & usage, warnings, otc - keep out of reach of children, otc - pregnancy or breast feeding, dosage & administration, storage and handling, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Topical analgesic
Indications & Usage
Uses temporarily releives minor pain
Warnings
Warnings for external use only.
Do not use
•more than one patch on your body at a time or on cut •on wounds or damaged skin •with a heating pad
When using this product
•avoid contact with eyes, mucous membranes or rashes •use only as directed •do not bandage tightly
•do not use at the same time as other topical analgesics •dispose of used patch in a manner that always keeps products away from children and pets
Stop use and ask a doctor if
•you experience signs of skin injury, such as pain, swelling or blistering where product was applied •symptoms persist for more than 7
days or clear up and occur again within a few days •condition worsens •redness is present •irritation develops
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. On case of accidental ingestion, get medical help or contact a Poison Control Center right away.
Otc - Pregnancy Or Breast Feeding
Pregnancy.breast-feeding warning. If pregant or breast-feeding, ask a health professional before use.
Dosage & Administration
Directions Adults and children 12 years of age and over:
•Clean and dry affected area •Remove film from patch and apply to the skin (see package for instructions)
•Apply to affected area not more than 3 to 4 times daily •Remove patch from the skin after at most 8 hours of application
Children under 12 years of age: consult a physician
Storage And Handling
Other information
•Store at room temperature 58° - 86° F (15° - 30° C). Acoid storing product in direct sunlight •Protect product from excessive moisture
Inactive Ingredient
Inactive ingredients DIHYDROXYALUMINUM AMINOACETATE, GLYCERIN, KAOLIN, METHYLPARABEN, PROPYLPARABEN, PROPYLENE GLYCOL,
PVP, POLYACRYLIC ACID, POLYSORBATE 80, SODIUM POLYACRYLATE, TITANIUM DIOXIDE, TARTARIC ACID, WATER
Package Label.Principal Display Panel
Image Description (Foshan 01)
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