Label: DR SABHARWALS- lidocaine 4% and menthol 1% patch patch
- NDC Code(s): 71318-115-15
- Packager: Dr. Sabharwal's Wound Care
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 30, 2024
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- ACTIVE INGREDIENT
- PURPOSE
- INTENDED USE OF THE DEVICE
- WARNINGS
- DO NOT USE
-
WHEN USING
- use only as directed. Read and follow all directions and warnings on this label.
- do not allow contact with the eyes
- 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 analgesics
- dispose of used patch in manner that always keeps product away from children or pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.
- ASK DOCTOR
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
-
INSTRUCTIONS FOR USE
Adults and children over 12 years:
- clean and dry affected area
- remove backing from patch by firmly grasping both ends and gently pulling until backing separates in middle
- carefully remove smaller portion of backing from patch and apply exposed portion of patch to affected area
- once exposed portion of patch is positioned, carefully remove remaining backing to completely apply patch to affected area
- use 1 patch for up to 12 hours
children 12 years or younger:
- ask a doctor
-
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
- DOSAGE & ADMINISTRATION
- INDICATIONS & USAGE
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
DR SABHARWALS
lidocaine 4% and menthol 1% patch patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71318-115 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 224 mg MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 56 mg Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SORBITAN MONOOLEATE (UNII: 06XEA2VD56) POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W) KAOLIN (UNII: 24H4NWX5CO) SORBITOL (UNII: 506T60A25R) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) DMDM HYDANTOIN (UNII: BYR0546TOW) SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L) CARBOMER 940 (UNII: 4Q93RCW27E) POLYVINYL ALCOHOL (100000 MW) (UNII: 949E52Z6MY) TARTARIC ACID (UNII: W4888I119H) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) GLYCERIN (UNII: PDC6A3C0OX) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) 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:71318-115-15 15 in 1 CARTON 01/30/2024 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 Drug M017 01/30/2024 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(71318-115)