LEADER CAPSAICIN- capsaicin cream

LEADER CAPSAICIN by

Drug Labeling and Warnings

LEADER CAPSAICIN by is a Otc medication manufactured, distributed, or labeled by CARDINAL HEALTH. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient                                                                      Purpose

Capsaicin 0.1%........................................................................Topical analgesic

PURPOSE

For the temporary relief of minor pain associated with:

• Arthritis
• Simple backache
• Muscle strains
• Sprains
• Bruises
  

WARNINGS

Warnings

For external use only

WHEN USING

When using this product

• use only as directed
• do not bandage
• do not use with heating pad
• avoid contact with eyes and mucous membranes
• do not apply to wounds, damaged, broken or irritated skin
• a slight burning
• sensation may occur upon application but generally disappears in several days
• if severe burning occurs, discontinue use
• do not expose the treated area to heat or direct sunlight
• do not use if allergic to capsicum or chili peppers
  

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
• irritation develops
  

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.

In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE

Directions

Adults and children over 18 years:

• apply generously to affected area not more than 3 to 4 times daily
• massage into painful area until thoroughly absorbed
• wash hands with soap and water after use
• close cap tightly after use

Children 18 years or younger: Ask a doctor

INACTIVE INGREDIENT

Inactive ingredients

Benzyl alcohol, cetyl alcohol, citric acid, glyceryl stearate SE, isopropyl myristate, PEG 100 stearate, petrolatum, purified water, sorbitol

DOSAGE & ADMINISTRATION

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017

CIN 3696283

www.myleader.com

1-800-200-6313

Made in Korea

PRINCIPAL DISPLAY PANEL

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INGREDIENTS AND APPEARANCE

LEADER CAPSAICIN 
capsaicin cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37205-641
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	0.1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
BENZYL ALCOHOL (UNII: LKG8494WBH)
CETYL ALCOHOL (UNII: 936JST6JCN)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
PEG-100 STEARATE (UNII: YD01N1999R)
PETROLATUM (UNII: 4T6H12BN9U)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37205-641-13	1 in 1 CARTON
1		42 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	03/01/2012

Labeler - CARDINAL HEALTH (097537435)