CAMPO PHARMA MUSCLE HOT- capsaicin cream

Campo pharma Muscle hot by

Drug Labeling and Warnings

Campo pharma Muscle hot by is a Otc medication manufactured, distributed, or labeled by Latin Shots, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

• In case of accidental ingestion, seek professional asistance 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 few days, discontinue use, and consult a doctor. 

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

Directions:

• This product is a storng counterirritant. Apply sparingly. Adults and children 6 years of age older: apply to affected area nor more thna 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 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:

INGREDIENTS AND APPEARANCE

CAMPO PHARMA MUSCLE HOT 
capsaicin cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82777-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	0.5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
MINERAL OIL (UNII: T5L8T28FGP)
PARAFFIN (UNII: I9O0E3H2ZE)
PETROLATUM (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82777-001-01	397 g in 1 JAR; Type 0: Not a Combination Product	09/01/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	09/01/2022

Labeler - Latin Shots, Inc (080681098)