CAMPO PHARMA MUSCLE HOT- capsaicin cream 
Latin Shots, Inc

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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Campo pharma Muscle hot

Drug Facts

Active Ingredients

Capsaicin 0.050%

Purpose

Counterrirriant

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: 

External use only

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

Directions:

Other information:

This product is intended to and will cause mild skin irritation. Discontinue use it 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 ingredient:

Mineral Oil, Paraffin, Petrolatum

Package Labeling:

Label2

CAMPO PHARMA MUSCLE HOT 
capsaicin cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82777-001
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:82777-001-01397 g in 1 JAR; Type 0: Not a Combination Product09/01/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34809/01/2022
Labeler - Latin Shots, Inc (080681098)

Revised: 1/2023
Document Id: f268454a-cffb-0724-e053-2995a90ae8bf
Set id: fc56701c-7cc7-4c24-8b24-35c00f390549
Version: 2
Effective Time: 20230116
 
Latin Shots, Inc