Label: TRUE LIDO GEL PATCH- lidocaine hcl patch
- NDC Code(s): 83035-1131-1
- Packager: Singular Dreamer, Ltd dba True Marker
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated June 24, 2024
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- Official Label (Printer Friendly)
- Active Ingredient Purposes
- PURPOSE
- Uses
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Warnings
- For External Use only
- Do not use: ● More than 1 patch at a time ● On wounds or damaged skin ● With a heating pad ● If you are allergic to any ingredients of this product
- When using this product: ● Use only as directed ● Avoid contact with eyes, mucous membranes or rashes ● Do not bandage tightly
- If pregnant or breast-feeding, ask a health professional before use.
- Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
- 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
- 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 or Comments
- Product label
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INGREDIENTS AND APPEARANCE
TRUE LIDO GEL PATCH
lidocaine hcl patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83035-1131 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE 4 g in 100 g Inactive Ingredients Ingredient Name Strength DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6) EDETATE DISODIUM (UNII: 7FLD91C86K) GLYCERIN (UNII: PDC6A3C0OX) KAOLIN (UNII: 24H4NWX5CO) METHYLPARABEN (UNII: A2I8C7HI9T) POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W) POLYSORBATE 80 (UNII: 6OZP39ZG8H) POVIDONE K90 (UNII: RDH86HJV5Z) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J) TARTARIC ACID (UNII: W4888I119H) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83035-1131-1 15 in 1 BOX 05/28/2024 11/01/2024 1 1 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 M017 05/28/2024 11/01/2024 Labeler - Singular Dreamer, Ltd dba True Marker (129504103) Registrant - Singular Dreamer, Ltd dba True Marker (129504103)