RED HOT- capsaicin ointment 
The Hygenic Company, LLC

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Red hot ointment

Drug Facts

Active Ingredients

Methyl Salicylate 12.5%

Capsaicin 0.025%

Purpose

Counterirritant

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with strains, sprains, tendonitis, simple backache, and arthritis. Combined with stretching and calisthenics, Red Hot assists in the warm-up process, especially in cool, damp weather.

Warnings

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately. Use only as directed. If condition worsens, or if the symptoms persist for more than 7 days, or clear up and occur again within a few days, discontinue use and consult a doctor. For external use only.

Keep this and all drugs out of the reach of children.

Directions

This product is a strong counterirritant. Apply sparingly. Adults and children 6 years of age and older: apply to affected area not more than 3 - 4 times daily. Children under 6 years of age: consult a doctor.

Other Information

This product is intended to and will cause mild skin irritation. Discontinue use if excessive irritation of skin develops. Avoid getting into eyes or on mucous membranes. Do not apply to irritated or broken skin. Store in a cool, dry place with lid closed tightly.

Inactive Ingredients

Mineral Oil, Paraffin, Petrolatum

Questions?

(800) 345-2231

Package Labeling:

Label8

RED HOT 
capsaicin ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82345-855
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
MINERAL OIL (UNII: T5L8T28FGP)  
PARAFFIN (UNII: I9O0E3H2ZE)  
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82345-855-01454 g in 1 BOTTLE; Type 0: Not a Combination Product04/01/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01704/01/2022
Labeler - The Hygenic Company, LLC (004163390)

Revised: 10/2023
Document Id: 0884b4eb-7fd2-b2c7-e063-6294a90aa02e
Set id: d100092c-e10b-2063-e053-2995a90aedb2
Version: 3
Effective Time: 20231025
 
The Hygenic Company, LLC