Label: PAIN RELIEVING- menthol gel
- NDC Code(s): 37205-824-26
- Packager: Cardinal Health
- 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 22, 2021
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredients
- Uses
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Warnings:
For external use only
When Using This Product:
• Avoid contact with eyes or mucous membranes
• Do not apply to wounds, damaged or irritated skin, or if excessive irritation develops
• Do not bandage or use with heating pad or device. ointments, creams, sprays. liniments
• Wash hands after with cool water
- Directions:
- Other Information:
- Inactive Ingredients:
- Package Labeling:
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INGREDIENTS AND APPEARANCE
PAIN RELIEVING
menthol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37205-824 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM 35 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ISOPROPYL ALCOHOL (UNII: ND2M416302) TROLAMINE (UNII: 9O3K93S3TK) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) METHYLPARABEN (UNII: A2I8C7HI9T) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37205-824-26 1 in 1 CARTON 01/18/2012 12/31/2024 1 118 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 not final part348 01/18/2012 12/31/2024 Labeler - Cardinal Health (097537435) Establishment Name Address ID/FEI Business Operations Span Packaging Services LLC 117101131 manufacture(37205-824) Establishment Name Address ID/FEI Business Operations Span Packaging Services LLC 557434805 manufacture(37205-824)