Label: ARCTIC RELIEF- menthol and camphor (synthetic) gel
- NDC Code(s): 58980-615-40
- Packager: Stratus Pharmaceuticals, Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
NOTE: Most over the counter (OTC) are not reviewed and approved by the 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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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
Active Ingredients Purpose Natural Menthol USP 3.5% Cooling Pain Reliever Camphor 0.2% Topical Analgesic
- Inactive Ingredients
carbomer, FD&C blue #1, FD&C yellow #5, herbal extract, isopropyl alcohol, methyl paraben, camphor, silicon dioxide, trolamine and purified waterClose
Temporary relief from minor aches and pains of sore muscles & joints associated with
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.
Stop Use And Ask A Doctor If: Condition worsens, or if symptoms persist for more than 7 days, or clear up and recur.
Keep out of reach of children: If accidentally ingested, get medical help or contact A Poison Control Center immediately.
- 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.Close
- Questions or Comments?
Call Customer Service at 800-442-7882Close
- SPL UNCLASSIFIED SECTION
Stratus Pharmaceuticals Inc.
12379 S.W. 130th Street
Miami, FL 33186
- PRINCIPAL DISPLAY PANEL - 113.4 g Tube Box
PAIN RELIEVING GEL
Net WT. 4 oz. / 113.4 grams
•GREASELESS •STAINLESS •VANISHING SCENT
PENETRATING, LONG-LASTING PAIN RELIEF FROM:
ARTHRITIS, SORE MUSCLES & JOINTS AND BACK PAIN.
- INGREDIENTS AND APPEARANCE
menthol and camphor (synthetic) gel
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58980-615 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol 3.969 g in 113.4 g Camphor (Synthetic) (UNII: 5TJD82A1ET) (Camphor (Synthetic) - UNII:5TJD82A1ET) Camphor (Synthetic) 0.2268 g in 113.4 g Inactive Ingredients Ingredient Name Strength carbomer homopolymer type c (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) methylparaben (UNII: A2I8C7HI9T) silicon dioxide (UNII: ETJ7Z6XBU4) trolamine (UNII: 9O3K93S3TK) water (UNII: 059QF0KO0R) 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 1 113.4 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 10/01/2009 Labeler - Stratus Pharmaceuticals, Inc (789001641) Establishment Name Address ID/FEI Business Operations Sonar Products, Inc 104283945 MANUFACTURE(58980-615)