Label: LIDOCAINE PATCH- lidocaine 4%, menthol 1% patch
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Contains inactivated NDC Code(s)
NDC Code(s): 81484-901-01, 81484-901-02, 81484-901-03, 81484-901-04 - Packager: Anhui Miao De Tang Pharmaceutical Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 14, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
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WHEN USING
use only as directod. Read and follow all directions and warnings on this label.
rare cases of serious bums 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 analgesics - STOP USE
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Adults and children 12 years of age and over:
clean and dry aftecied area
remove backing from patch by firmly grasping both ends and gently pulling until backing separates in middle
carefully remave smaller portion of backing from patch and apply exposed portion of patch to atlected area
once exposed portion of patch is positioned, carefully remove remaining backing to completely applypatch to aitected area
use 2 patch tor up to 24 hours
Children under 12 years of age:consult a doctor - STORAGE AND HANDLING
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
LIDOCAINE PATCH
lidocaine 4%, menthol 1% patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81484-901 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 0.01 g LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 0.04 g Inactive Ingredients Ingredient Name Strength POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W) SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J) UREA (UNII: 8W8T17847W) TARTARIC ACID (UNII: W4888I119H) WATER (UNII: 059QF0KO0R) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K) CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) METHYLPARABEN (UNII: A2I8C7HI9T) POLYSORBATE 80 (UNII: 6OZP39ZG8H) CASTOR OIL (UNII: D5340Y2I9G) GLYCERIN (UNII: PDC6A3C0OX) POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81484-901-03 2 in 1 PACKAGE 09/14/2023 1 NDC:81484-901-02 6 in 1 BOX 1 NDC:81484-901-01 1 in 1 BAG; Type 0: Not a Combination Product 2 NDC:81484-901-04 30 in 1 BOX 11/14/2023 2 NDC:81484-901-01 1 in 1 BAG; 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 09/14/2023 Labeler - Anhui Miao De Tang Pharmaceutical Co., Ltd. (405744102) Establishment Name Address ID/FEI Business Operations Anhui Miao De Tang Pharmaceutical Co., Ltd. 405744102 manufacture(81484-901)