Label: 1ST RELIEF TOPICAL- lidocaine and menthol spray
- NDC Code(s): 69094-226-04
- Packager: 1st Class Pharmaceuticals, Inc.
- 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 December 28, 2017
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT:
- PURPOSE
- Indications:
- Warnings:
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other Ingredients:
- PREGNANCY OR BREAST FEEDING
- Package Label
-
INGREDIENTS AND APPEARANCE
1ST RELIEF TOPICAL
lidocaine and menthol sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69094-226 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 40 mg in 1 mL MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 10 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) BOSWELLIA SERRATA WHOLE (UNII: X7B7P649WQ) CETYL MYRISTOLEATE (UNII: 87P8K33Q5X) EMU OIL (UNII: 344821WD61) GLYCYRRHIZA GLABRA LEAF (UNII: GH32M797Y9) DIMETHYL SULFONE (UNII: 9H4PO4Z4FT) POLYSORBATE 20 (UNII: 7T1F30V5YH) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) SODIUM BENZOATE (UNII: OJ245FE5EU) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69094-226-04 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 12/02/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 12/02/2014 Labeler - 1st Class Pharmaceuticals, Inc. (079448685)