Label: WALGREENS COLD PAIN RELIEF- menthol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 0363-0864-03 - Packager: Walgreens, Co
- 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 February 5, 2021
If you are a consumer or patient please visit this version.
- 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 the eyes or mucous membranes • Do not apply to wounds or damaged skin • Do not use with other ointments, creams, sprays, or liniments • Do not apply to irritated skin or if excessive irritation develops • Do not bandage • Wash hands after use with cool water • Do not use with heating pad or device • Store in a cool dry place.
- Directions
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Inactive Ingredients
Aloe Barbadensis Leaf Extract, Arctium Lappa Root (Burdock) Extract, Arnica Montana Flower Extract, Blue 1, Boswellia Carterii Resin Extract, Calendula Officinalis Extract, Camellia Sinensis Leaf Extract, Camphor, Carbomer, Glycerin, Ilex Paraguariensis Leaf Extract, Isopropyl Alcohol, Isopropyl Myristate, Melissa Officinalis (Lemon Balm) Leaf Extract, Silica, Tocopheryl Acetate, Triethanolamine, Water, Yellow 5
- Questions or Comments:
- Package Labeling:
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INGREDIENTS AND APPEARANCE
WALGREENS COLD PAIN RELIEF
menthol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0864 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 40 mg in 1 mL Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3) ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FRANKINCENSE (UNII: R9XLF1R1WM) CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) GREEN TEA LEAF (UNII: W2ZU1RY8B0) CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) GLYCERIN (UNII: PDC6A3C0OX) ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F) ISOPROPYL ALCOHOL (UNII: ND2M416302) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) TROLAMINE (UNII: 9O3K93S3TK) WATER (UNII: 059QF0KO0R) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-0864-03 89 mL in 1 BOTTLE; Type 0: Not a Combination Product 02/06/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 02/06/2018 Labeler - Walgreens, Co (008965063) Establishment Name Address ID/FEI Business Operations Span Packaging Services LLC 117101131 manufacture(0363-0864) Establishment Name Address ID/FEI Business Operations Cosmetic Essence, LLC 825646862 manufacture(0363-0864)