Label: LEADER CAPSAICIN- capsaicin cream
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Contains inactivated NDC Code(s)
NDC Code(s): 37205-641-13 - Packager: CARDINAL HEALTH
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated March 1, 2012
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- WARNINGS
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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
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- INACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
LEADER CAPSAICIN
capsaicin creamProduct 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)