CAJUN HOT ICE MUSCLE AND JOINT PAIN RUB- menthol, camphor, capsaicin gel

Cajun Hot Ice Muscle and Joint Pain Rub by

Drug Labeling and Warnings

Cajun Hot Ice Muscle and Joint Pain Rub by is a Otc medication manufactured, distributed, or labeled by Cajun Therapeutics, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Menthol 9.00%; Camphor 3.00%, Capsaicin 0.025%

Purpose

Topical Analgesic

Uses

For the temporary relief of minor aches and pains of the muscles and joints

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

Stop use and ask a doctor if

• Symptoms persist for more than seven days, discontinue use and consult a physician
• Rash/blistering occurs
• Difficulty breathing or swallowing occurs
• Severe burning pain persists

Keep out the reach of children.

If swallowed, get medical help or contact a poison control center immediately. If pregnant or breastfeeding, ask a physician before use.

Directions

• Apply to affected area and gently massage until cream is thoroughly absorbed
• Repeat up to three to four times daily
• Unless treating hands, wash hands thoroughly with soap and water immediately after use
• For persons under 18 years old, consult a physician before using

Other information:

This product may cause allergic reactions in some individuals. Test on a small area before use. Stop use and ask a doctor if blisters develop.

Inactive Ingredients:

Acrylates/c10-30 Alkyl Acrylate Crosspolymer, Aqua (Deionized Water), Cetyl Alcohol, Capsaicin, Ethylhexylglycerin, Helianthus Annuus (Sunflower) Oil, Isopropyl Myristate, Methylsulfonylmethane, Phenoxyethanol, Sodium Lauryl Sulfate, Stearic Acid, Triethanolamine, Parfum (Fragrance).

Package Labeling:

INGREDIENTS AND APPEARANCE

CAJUN HOT ICE MUSCLE AND JOINT PAIN RUB 
menthol, camphor, capsaicin gel

Product 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)