Label: LIDOCAINE HCL 4 PERCENT AND MENTHOL 4 PERCENT- lidocaine hcl and menthol spray
- NDC Code(s): 70645-263-11
- Packager: 7T Pharma LLC
- 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 June 27, 2018
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Uses
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Warnings
For external use only.
When using this product
- do not use in or near the eyes
- do not use in large quantities, particularly over raw surfaces or blistered areas
- do not use in or near the eyes
- Directions
- Other information
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Inactive ingredients
Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Cetyl Myristoleate, Ethylhexylglycerin, Glycyrrhiza Glabra (Licorice) Extract, Ilex Paraguaiensis (Yerba Mate) Extract, Magnesium Sulfate, Methylsulfonylmethane (MSM), Phenoxyethanol, Polysorbate-20, SD-Alcohol 40B
Lidocaine 4% and Menthol 4% Topical Spray
NDC 70645-263-11
4 fl oz (118mL)
Manufactured for:
7T Pharma, LLC
Los Angeles, CA 90064 - PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
LIDOCAINE HCL 4 PERCENT AND MENTHOL 4 PERCENT
lidocaine hcl and menthol sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70645-263 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS 4 g in 100 mL MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 4 g in 100 mL Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) WATER (UNII: 059QF0KO0R) ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) INDIAN FRANKINCENSE (UNII: 4PW41QCO2M) CETYL MYRISTOLEATE (UNII: 87P8K33Q5X) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F) MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB) DIMETHYL SULFONE (UNII: 9H4PO4Z4FT) PHENOXYETHANOL (UNII: HIE492ZZ3T) POLYSORBATE 20 (UNII: 7T1F30V5YH) ALCOHOL (UNII: 3K9958V90M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70645-263-11 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 06/01/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part348 06/01/2018 Labeler - 7T Pharma LLC (080220022)