Label: ZYLOTROL MAXIMUM PAIN- lidocaine 4%, menthol 1% patch
- NDC Code(s): 81902-104-15
- Packager: Whitestone Products LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 21, 2023
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- Official Label (Printer Friendly)
- Active Ingredients
- Purposes
- 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
Adult 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-hour application
Children under 12 years of age: Consult a doctor
- Other information
- Inactive Ingredients
- Questions?
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
ZYLOTROL MAXIMUM PAIN
lidocaine 4%, menthol 1% patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81902-104 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 0.03 g in 3 g LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 0.12 g in 3 g Inactive Ingredients Ingredient Name Strength KAOLIN (UNII: 24H4NWX5CO) TARTARIC ACID (UNII: W4888I119H) WATER (UNII: 059QF0KO0R) DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W) SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) MINERAL OIL (UNII: T5L8T28FGP) POLYSORBATE 80 (UNII: 6OZP39ZG8H) GLYCERIN (UNII: PDC6A3C0OX) EDETATE DISODIUM (UNII: 7FLD91C86K) POVIDONE K90 (UNII: RDH86HJV5Z) HYDROXYACETOPHENONE (UNII: G1L3HT4CMH) Product Characteristics Color brown Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81902-104-15 15 in 1 BOX 12/23/2022 1 3 g in 1 PATCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug 505G(a)(3) 12/23/2022 Labeler - Whitestone Products LLC (118064415)