CVS MEDICATED HEAT- capsicum extract patch

CVS Medicated Heat by

Drug Labeling and Warnings

CVS Medicated Heat by is a Otc medication manufactured, distributed, or labeled by CVS Pharmacy. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient Purpose

Capsicum extract 0.025% as Capsaicin.....................Topical analgesic

PURPOSE

Uses

temporarily relieves minor pain of muscles and joints associated with:

• arthritis
• simple backache
• strains
• sprains
• bruises

WARNINGS

Warnings

For External use only

Allergy alert:

• do not use if you are allergic to capsicum, chili peppers, or any ingredients in this product
• if prone to allergic reaction from aspirin or salicylates, consult a doctor before use

DO NOT USE

Do not use

• on wounds or damaged skin
• with a heating pad

WHEN USING

When using this product

• do not use otherwise than directed
• avoid contact with the eyes, mucous membranes or rashes
• do not bandage tightly
• discontinue use at least 1 hour before a bath or shower
• do not use immediately after a bath or shower

STOP USE

Stop use and ask a doctor if

• condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days
• redness is present or irritation or rash develops
• a severe burning sensation occurs

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

INDICATIONS & USAGE

Directions

• adults and children 12 years of age and older:
• clean and dry affected area
• remove patch from film
• apply to affected area no more than 3 to 4 times daily
• do not wear patch for more than 8 hours
• children under 12 years of age: consult a doctor

STORAGE AND HANDLING

Other information

• avoid storing product in direct sunlight
• protect product from excessive moisture

INACTIVE INGREDIENT

Inactive ingredients

lanolin, methyl salicylate, natural rubber, peppermint oil, petrolatum, rosin, zinc oxide

DOSAGE & ADMINISTRATION

Distributed by:

CVS Pharmacy, Inc.

One CVS Drive

Woonsocket, RI 02895

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CVS MEDICATED HEAT 
capsicum extract patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69842-091
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAPSICUM (UNII: 00UK7646FG) (CAPSICUM - UNII:00UK7646FG)	CAPSICUM	0.025 mg

Inactive Ingredients
Ingredient Name	Strength
METHYL SALICYLATE (UNII: LAV5U5022Y)
NATURAL LATEX RUBBER (UNII: 2LQ0UUW8IN)
LANOLIN (UNII: 7EV65EAW6H)
PEPPERMINT OIL (UNII: AV092KU4JH)
PETROLATUM (UNII: 4T6H12BN9U)
ZINC OXIDE (UNII: SOI2LOH54Z)
ROSIN (UNII: 88S87KL877)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69842-091-03	3 in 1 POUCH	02/13/2019
1		1 in 1 PATCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	02/13/2019

Labeler - CVS Pharmacy (062312574)