RED HOT- capsaicin ointment 
Performance Health, 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.

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Red Hot Ointment

Drug Facts

Active Ingredients

Capsaicin 0.050%

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

For external use only.

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.

Keep this and all drugs out of 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:

Label

RED HOT 
capsaicin ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59316-996
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.05 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
MINERAL OIL (UNII: T5L8T28FGP)  
PARAFFIN (UNII: I9O0E3H2ZE)  
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59316-996-2178 g in 1 TUBE; Type 0: Not a Combination Product05/19/201712/31/2024
2NDC:59316-996-96454 g in 1 BOTTLE; Type 0: Not a Combination Product05/19/201712/31/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34805/19/201712/31/2024
Labeler - Performance Health, LLC (794324061)

Revised: 8/2022
Document Id: e5b3695c-7183-66de-e053-2a95a90a68c5
Set id: 7297337a-d389-4aa8-99f1-46b116741002
Version: 5
Effective Time: 20220807
 
Performance Health, LLC