Label: LIDOZEN- lidocaine hydrochloride, menthol gel
- NDC Code(s): 63187-892-64, 63187-892-72
- Packager: Proficient Rx LP
- This is a repackaged label.
- Source NDC Code(s): 71574-300
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 1, 2023
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- DRUG FACTS:
- ACTIVE INGREDIENTS:
- USES:
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WARNINGS:
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- For external use only.
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- Avoid contact with eyes.
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- If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician.
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- Do not use in large quantities, particularly over raw surfaces or blistered areas.
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- If pregnant or breast-feeding, ask a health professional before use.
- DIRECTIONS (Adults and Children Over 12 Years):
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INACTIVE INGREDIENTS:
Aloe Barbadensis Leaf (Aloe Vera Juice) Gel, Aqua (Deionized Water), Arnica Montana Extract, Boswellia Serrata Extract, Camellia Sinensis Leaf (Green Tea) Extract, Carbomer, Ethylhexylglycerin, Glycerin, Isopropyl Myristate, PEG-8, Phenoxyethanol, Polysorbte-80, Sodium Lauryl Sulfate, Triethanolamine, FD&C Blue #1, FD&C Yellow #5
- Package Labeling:
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INGREDIENTS AND APPEARANCE
LIDOZEN
lidocaine hydrochloride, menthol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63187-892(NDC:71574-300) Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE 40 mg in 1 mL MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM 10 mg in 1 mL Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) WATER (UNII: 059QF0KO0R) ARNICA MONTANA WHOLE (UNII: O80TY208ZW) INDIAN FRANKINCENSE (UNII: 4PW41QCO2M) GREEN TEA LEAF (UNII: W2ZU1RY8B0) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) GLYCERIN (UNII: PDC6A3C0OX) TROLAMINE (UNII: 9O3K93S3TK) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) PHENOXYETHANOL (UNII: HIE492ZZ3T) POLYSORBATE 80 (UNII: 6OZP39ZG8H) SODIUM LAURYL SULFATE (UNII: 368GB5141J) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63187-892-72 1 in 1 BOX 08/01/2017 1 120 mL in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:63187-892-64 2 in 1 BOX 11/13/2020 11/30/2023 2 120 mL in 1 BOTTLE; 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 07/22/2017 Labeler - Proficient Rx LP (079196022) Establishment Name Address ID/FEI Business Operations Proficient Rx LP 079196022 RELABEL(63187-892)
