Label: LIDOCAINE patch
- NDC Code(s): 30142-697-91
- Packager: Kroger Company
- 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 May 20, 2019
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Uses
- Warnings
- Do not use
- When using this product
- Stop use and ask a doctor if
- If pregnant or breast-feeding,
- Keep out of reach of children.
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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 illustration)
- •
- apply 1 patch at a time 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 doctor
- Other information
- Inactive ingredients
- Questions or comments?
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Package/Label Principal Display Panel
COMPARE TO the active ingredient of SALONPAS® LIDOCAINE PATCH See back panel.
Maximum Strength
Lidocaine Patch
4% Lidocaine/Topical Anesthetic
For Back, Neck, Knees, Shoulders & Elbows
Up to 8 Hours of Relief
For Temporary Relief of Pain
Desensitize Aggravated Nerves
Numbing Relief
Unscented
6 PATCHES
3 15/16 IN X 5 ½ IN (10cm x 14cm)
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INGREDIENTS AND APPEARANCE
LIDOCAINE
lidocaine patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:30142-697 Route of Administration TOPICAL, PERCUTANEOUS, TRANSDERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 4 mg Inactive Ingredients Ingredient Name Strength CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6) EDETATE DISODIUM (UNII: 7FLD91C86K) GLYCERIN (UNII: PDC6A3C0OX) KAOLIN (UNII: 24H4NWX5CO) METHYLPARABEN (UNII: A2I8C7HI9T) POLYVINYL ALCOHOL (UNII: 532B59J990) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) TARTARIC ACID (UNII: W4888I119H) UREA (UNII: 8W8T17847W) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:30142-697-91 6 in 1 CARTON 05/17/2019 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 05/17/2019 Labeler - Kroger Company (006999528)