RITE AID CAPSICUM HOT- capsaicin patch

RITE AID CAPSICUM HOT by

Drug Labeling and Warnings

RITE AID CAPSICUM HOT by is a Otc medication manufactured, distributed, or labeled by RITE AID CORPORATION. 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 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

DO NOT USE

Do not use

• on wounds or damaged skin
• with a heating pad

WHEN USING

When using this product

• avoid contact with eyes and 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

• conditions worsens, symptoms persist 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 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

butylhydroxytoluene, glyceryl rosinate, isopropyl myristate, natural rubber, polybutene, polyisobutylene, carbonate, propylene carbonate, sorbitan stearate, terpene resin (quinton), terpene resin (ys resin), titanium dioxide, zinc oxide

DOSAGE & ADMINISTRATION

DISTRIBUTED BY:

RITE AID, 30 HUNTER LANE

CAMP HILL, PA 17011

MADE IN KOREA

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

RITE AID CAPSICUM HOT 
capsaicin patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11822-5744
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	0.6 mg

Inactive Ingredients
Ingredient Name	Strength
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
NATURAL LATEX RUBBER (UNII: 2LQ0UUW8IN)
POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
ZINC OXIDE (UNII: SOI2LOH54Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11822-5744-3	3 in 1 POUCH; Type 0: Not a Combination Product	11/30/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	11/30/2012

Labeler - RITE AID CORPORATION (014578892)