Label: ARCTIC RELIEF- menthol, unspecified form gel
- NDC Code(s): 58980-615-40
- Packager: STRATUS 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 August 9, 2022
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredient
- Purpose
- Inactive Ingredients
- Uses
-
Warnings
FOR EXTERNAL USE ONLY.
Flammable: Keep away from excessive heat or open flame.
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 a heating pad or device.
- Directions
- Other Information
- Questions or Comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 113.4 gram Tube Box
-
INGREDIENTS AND APPEARANCE
ARCTIC RELIEF
menthol, unspecified form gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58980-615 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 3.969 g in 113.4 g Inactive Ingredients Ingredient Name Strength CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F) ISOPROPYL ALCOHOL (UNII: ND2M416302) Product Characteristics Color GREEN Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58980-615-40 1 in 1 BOX 09/15/2017 1 113.4 g in 1 TUBE; 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 09/15/2017 Labeler - STRATUS PHARMACEUTICALS INC (789001641) Establishment Name Address ID/FEI Business Operations TARMAC PRODUCTS INC 059890491 MANUFACTURE(58980-615)