Label: LIDOCAINE 4% GEL PATCH patch
- NDC Code(s): 71318-112-15
- Packager: Dr. Sabharwal's Wound Care
- Category: HUMAN OTC DRUG LABEL
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 August 28, 2023
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- ACTIVE INGREDIENT
- INDICATIONS & USAGE
- PURPOSE
- WARNINGS
- DO NOT USE
-
WHEN USING
Use only as directed.
Read and follow all directions and warnings on this label.
Rare case of serious burns have been reported with products of this type.
Do not apply to wounds or damaged, broken or irritated skin.
Do not allow contact with the eyes and mucous membranes.
Do not bandage tightly or apply local heat (such as heating pads) to the area of use.
Do not use at the same time as other topical analgesic.
Dispose of used patch in manner that always keeps product away from children and pets.
Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch
A transient burning sensation may occur uopn application but generally disappears in several days.
If a severe burning sensation occurs, discontinue use immediately.
Discontinue use at least 1 hour before a bath or shower.
Do not use immediately after a bath or shower. - Stop use and ask a doctor if
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
-
INSTRUCTIONS FOR USE
Adult and children over 12 years
Clean and dry affected area.
Remove backing from patch by firmly grasping both ends and gently pulling until back separates in middle.
Carefully remove smaller portion of backing from the patch and apply exposed portion of patch to affected area.
Use 1 patch for up to 12 hours.Children 12 years or younger:
ask a doctor - STORAGE AND HANDLING
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INACTIVE INGREDIENT
Alpha Tocopherol Acetate, Aluminium Glycinate, Aluminium Hydroxide, Aluminium Sulphate, Borax, Carbomer, Collodial Silicon
Dioxide, DMDM Hydantoin, Glycerine, Kaolin, Polyacrylic Acid, Polyvinyl Alcohol, Polyvinylpyrrolidone, Propylene Glycol, Purified Water, Sodium Carboxymethyl Cellulose, Sodium Ethylenediaminetetraacetic Acid, Sodium Polyacrylate, Sorbitol, Sorbitan Monooleate, Tartaric Acid & Titanium Dioxide. - QUESTIONS
- 82349-2 - Section Title Not Found In Database
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
LIDOCAINE 4% GEL PATCH
lidocaine 4% gel patch patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71318-112 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 84 mg Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SORBITAN MONOOLEATE (UNII: 06XEA2VD56) POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W) DMDM HYDANTOIN (UNII: BYR0546TOW) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L) GLYCERIN (UNII: PDC6A3C0OX) KAOLIN (UNII: 24H4NWX5CO) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) CARBOMER 940 (UNII: 4Q93RCW27E) POLYVINYL ALCOHOL (100000 MW) (UNII: 949E52Z6MY) SORBITOL (UNII: 506T60A25R) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) TARTARIC ACID (UNII: W4888I119H) Product Characteristics Color white Score Shape RECTANGLE Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71318-112-15 15 in 1 CARTON 08/10/2023 1 1 in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 08/10/2023 Labeler - Dr. Sabharwal's Wound Care (862184668) Registrant - Dr. Sabharwal's Wound Care (862184668) Establishment Name Address ID/FEI Business Operations Dr. Sabharwal's Wound Care 862184668 manufacture(71318-112)