Label: ICY HOT PAIN RELIEVING STICK- menthol and methyl salicylate stick
ICY HOT PAIN RELIEVING BALM- menthol and methyl salicylate ointment
ICY HOT PAIN RELIEVING CREAM- menthol and methyl salicylate cream
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NDC Code(s):
41167-0087-9,
41167-0088-1,
41167-0088-5,
41167-0088-8, view more41167-0089-8
- Packager: Chattem, 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 March 30, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Uses
-
Warnings
For external use only
SEE INSIDE LABEL FOR COMPLETE DRUG FACTS
Allergy Alert: If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.
When using this product
■ use only as directed. Read and follow all directions and warnings on this label.
■ avoid contact with eyes and mucous membranes
■ rare cases of serious burns have been reported with products of this type
■ do not apply to wounds or damaged, broken or irritated skin
■ do not bandage tightly or apply local heat (such as heating pads) or a medicated patch to the area of use
■ a transient burning sensation may occur upon application but generally disappears in several days
■ if severe burning sensation occurs, discontinue use immediately
■ do not expose the area treated with product to heat or direct sunlight
- Directions
- Inactive ingredients
- Active ingredient
- Purpose
- Uses
-
Warnings
For external use only
Allergy alert: if prone to allergic reaction from aspirin or salicylates, consult a doctor before use
When using this product
■ use only as directed. Read and follow all directions and warnings on this label.
■ avoid contact with eyes and mucous membranes
■ rare cases of serious burns have been reported with products of this type
■ do not apply to wounds or damaged, broken or irritated skin
■ do not bandage tightly or apply local heat (such as heating pads) or a medicated patch to the area of use
■ do not use at the same time as other topical analgesics
■ a transient burning sensation may occur upon application but generally disappears in several days
■ if severe burning sensation occurs, discontinue use immediately
■ do not expose the area treated with product to heat or direct sunlight
■ avoid applying into skin folds
- Directions
- Inactive ingredients
- Active ingredient
- Purpose
- Uses
-
Warnings
For external use only
Allergy alert: if prone to allergic reaction from aspirin or salicylates, consult a doctor before use
When using this product
■ use only as directed. Read and follow all directions and warnings on this carton.
■ avoid contact with eyes and mucous membranes
■ rare cases of serious burns have been reported with products of this type
■ do not apply to wounds or damaged, broken or irritated skin
■ do not bandage tightly or apply local heat (such as heating pads) or a medicated patch to the area of use
■ do not use at the same time as other topical analgesics
■ a transient burning sensation may occur upon application but generally disappears in several days
■ if severe burning sensation occurs, discontinue use immediately
■ do not expose the area treated with product to heat or direct sunlight
■ avoid applying into skin folds
- Directions
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
ICY HOT PAIN RELIEVING STICK
menthol and methyl salicylate stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41167-0089 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 10 g in 100 g METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 30 g in 100 g Inactive Ingredients Ingredient Name Strength CERESIN (UNII: Q1LS2UJO3A) CYCLOMETHICONE (UNII: NMQ347994Z) HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) PARAFFIN (UNII: I9O0E3H2ZE) PEG-150 DISTEARATE (UNII: 6F36Q0I0AC) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) STEARIC ACID (UNII: 4ELV7Z65AP) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41167-0089-8 49 g in 1 JAR; Type 0: Not a Combination Product 06/01/1991 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 06/01/1991 ICY HOT PAIN RELIEVING BALM
menthol and methyl salicylate ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41167-0087 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 7.6 g in 100 g METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 29 g in 100 g Inactive Ingredients Ingredient Name Strength PARAFFIN (UNII: I9O0E3H2ZE) PETROLATUM (UNII: 4T6H12BN9U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41167-0087-9 99 g in 1 JAR; Type 0: Not a Combination Product 06/01/1991 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 06/01/1991 ICY HOT PAIN RELIEVING CREAM
menthol and methyl salicylate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41167-0088 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 10 g in 100 g METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 30 g in 100 g Inactive Ingredients Ingredient Name Strength CETYL ESTERS WAX (UNII: D072FFP9GU) OLETH-3 PHOSPHATE (UNII: 8Q0Z18J1VL) STEARIC ACID (UNII: 4ELV7Z65AP) WATER (UNII: 059QF0KO0R) TROLAMINE (UNII: 9O3K93S3TK) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41167-0088-1 1 in 1 CARTON 06/01/1991 1 85 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:41167-0088-5 1 in 1 CARTON 06/01/1991 2 35.4 g in 1 TUBE; Type 0: Not a Combination Product 3 NDC:41167-0088-8 1 in 1 CARTON 06/01/1991 3 44 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 06/01/1991 Labeler - Chattem, Inc. (003336013)