ARCTIC RELIEF PAIN RELIEVING GEL 5%

ARCTIC RELIEF PAIN RELIEVING by

Drug Labeling and Warnings

ARCTIC RELIEF PAIN RELIEVING by is a Otc medication manufactured, distributed, or labeled by STRATUS PHARMACEUTICALS INC, TARMAC PRODUCTS INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ARCTIC RELIEF PAIN RELIEVING- menthol, unspecified form gel 
STRATUS PHARMACEUTICALS INC

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.

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ARCTIC RELIEF PAIN RELIEVING GEL 5%

Drug Facts

Active Ingredients

Natural Menthol USP 5%

Purpose

Cooling Pain Reliever

Uses

Temporary relief from minor aches and pains of sore muscles & joints associated with

  • arthritis
  • backache
  • strains
  • sprains.

Warnings

  • For external use only.
  • Flammable: Keep away from excessive heat or open flame.

Ask a doctor before use if you have sensitive skin.

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

Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days, or clear up and recur.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children: If accidentally ingested, get medical help or contact a Poison Control Center immediately.

Directions

  • Adults and children 2 years of age and older: Rub a thin film over affected areas not more than 4 times daily; massage not necessary.
  • Children under 2 years of age: Consult physician.

Other Information

Store in a cool dry place with cap closed tightly. Protect from direct sunlight.

Inactive Ingredients

Aloe Barbadensis Leaf Extract, Arctium Lappa Root Extract, Boswellia Extract, Calendula Officinalis Extract, Camphor, Carbomer, Green Tea Leaf Extract, Ilex Paraguariensis Leaf Extract, Isopropyl Alcohol, Melissa Officinalisis, Methylparaben, Purified Water, Silicon Dioxide and Triethanolamine.

Questions or Comments?

Call Customer Service at 800-442-7882

Distributed by:
Stratus Pharmaceuticals Inc.
Miami, FL 33186

PRINCIPAL DISPLAY PANEL - 113.4 g Tube Box

NDC: 58980-618-40
Net WT. 4 oz. / 113.4 g

STRATUS
PHARMACEUTICALS INC

ARCTIC RELIEF
PAIN RELIEVING GEL

GREASELESS STAINLESS VANISHING SCENT

PENETRATING, LONG-LASTING PAIN RELIEF FROM:
ARTHRITIS, SORE MUSCLES, JOINTS AND BACK PAIN.

PRINCIPAL DISPLAY PANEL - 113.4 g Tube Box
ARCTIC RELIEF PAIN RELIEVING 
menthol, unspecified form gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 58980-618
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM5 g  in 113.4 g
Inactive Ingredients
Ingredient NameStrength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)  
BOSWELLIA SERRATA WHOLE (UNII: X7B7P649WQ)  
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
WATER (UNII: 059QF0KO0R)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
TROLAMINE (UNII: 9O3K93S3TK)  
MELISSA OFFICINALIS WHOLE (UNII: YF70189L0N)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 58980-618-401 in 1 BOX06/07/202106/01/2022
1113.4 g in 1 TUBE; Type 0: Not a Combination Product
2NDC: 58980-618-32907.2 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/07/202106/01/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34806/07/202106/01/2022
Labeler - STRATUS PHARMACEUTICALS INC (789001641)
Establishment
NameAddressID/FEIBusiness Operations
TARMAC PRODUCTS INC059890491MANUFACTURE(58980-618)

Revised: 10/2023
Document Id: 62fa44f0-a852-4944-a70d-f99a9fd2d298
Set id: cf1df0bc-ef2f-4d7d-acc1-28c438aabe67
Version: 4
Effective Time: 20231002