NDC | 70904-756-01 |
Set ID | f418e0db-6baf-48fb-a023-1d1bf3a1b848 |
Category | HUMAN OTC DRUG LABEL |
Packager | Cajun Therapeutics, LLC |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART348 |
- Active Ingredients
- Uses
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Warning
For external use only. Do not apply to wounds or damaged or irritated skin. Avoid contact with eyes and mucous membranes. If this occurs, wash the area thoroughly with water.
- You may experience a burning sensation when using this product which is normal and related to the way the product works. With regular use this sensation will disappear after several days.
- Do not apply immediately before or after activities such as strenuous exercise, bathing, swimming or sun bathing
- Do not tightly wrap or bandage the treated areas
- Do not apply heat or heating pad to the treated areas immediately before or after use
- Directions
- Other information:
- Inactive Ingredients:
- Package Labeling:
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INGREDIENTS AND APPEARANCE
CAJUN HOT ICE MUSCLE AND JOINT PAIN RUB
menthol, camphor, capsaicin gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70904-756 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL) 30 mg in 1 g MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 90 mg in 1 g CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN 0.25 mg in 1 g Inactive Ingredients Ingredient Name Strength CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) WATER (UNII: 059QF0KO0R) CETYL ALCOHOL (UNII: 936JST6JCN) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) DIMETHYL SULFONE (UNII: 9H4PO4Z4FT) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM LAURYL SULFATE (UNII: 368GB5141J) STEARIC ACID (UNII: 4ELV7Z65AP) TROLAMINE (UNII: 9O3K93S3TK) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70904-756-01 113 g in 1 TUBE; Type 0: Not a Combination Product 08/12/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 08/12/2016 Labeler - Cajun Therapeutics, LLC (079835064)