OTC Medication Information: Cajun Hot Ice Muscle and Joint Pain Rub

CAJUN HOT ICE MUSCLE AND JOINT PAIN RUB- camphor (natural), menthol and capsaicin gel
Cajun Therapeutics, LLC

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.

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:

Label
(click image for full-size original)

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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CAMPHOR (NATURAL) (CAMPHOR (NATURAL)) CAMPHOR (NATURAL) 30 mg in 1 g
MENTHOL (MENTHOL) MENTHOL 90 mg in 1 g
CAPSAICIN (CAPSAICIN) CAPSAICIN 0.25 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)
WATER
CETYL ALCOHOL
ETHYLHEXYLGLYCERIN
HELIANTHUS ANNUUS FLOWERING TOP
ISOPROPYL MYRISTATE
DIMETHYL SULFONE
PHENOXYETHANOL
SODIUM LAURYL SULFATE
STEARIC ACID
TROLAMINE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70904-756-01 113 g in 1 TUBE None
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)

Revised: 02/2017 Cajun Therapeutics, LLC

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2022. All Rights Reserved.