Label: ASSURED PAIN RELIEF- lidocaine gel
-
Contains inactivated NDC Code(s)
NDC Code(s): 69159-100-01 - Packager: Foshan Aqua Gel Biotech Co., Ltd.,
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated September 8, 2017
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
-
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
- KEEP OUT OF REACH OF CHILDREN
- PREGNANCY OR BREAST FEEDING
-
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
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
ASSURED PAIN RELIEF
lidocaine gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69159-100 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 4 g in 100 g Inactive Ingredients Ingredient Name Strength DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6) GLYCERIN (UNII: PDC6A3C0OX) KAOLIN (UNII: 24H4NWX5CO) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F) POLYSORBATE 80 (UNII: 6OZP39ZG8H) SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TARTARIC ACID (UNII: W4888I119H) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69159-100-01 15 g in 1 PATCH; Type 0: Not a Combination Product 08/20/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 08/20/2017 Labeler - Foshan Aqua Gel Biotech Co., Ltd., (529128763) Establishment Name Address ID/FEI Business Operations Foshan Aqua Gel Biotech Co., Ltd., 529128763 manufacture(69159-100)
