Label: CAPSAICIN- capsaicin 0.15% liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 36800-729-01 - Packager: Top Care
- 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 July 18, 2018
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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WARNINGS
Warnings
For external use only
When using this product • Use only as directed • Do not bandage tightly
• Do not use with a heating pad
• Avoid contact with eyes and mucous membranes
• Do not apply to wounds, damaged, broken or irritated skin
• A transient burning sensation may occur upon application but generally
disappears in several days
• If severe burning sensation occurs, discontinue use immediately and read
package insert for important information
• Do not expose the area treated with product to heat or direct sunlight
Stop use and ask a doctor if
• Condition worsens • Redness is present • Irritation develops
• Symptoms persist for more than 7 days or clear up and occur again within
a few days
Flammable Keep away from fire or flame - KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CAPSAICIN
capsaicin 0.15% liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-729 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Capsaicin (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) Capsaicin 0.15 g in 100 mL Inactive Ingredients Ingredient Name Strength CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E) Glycerin (UNII: PDC6A3C0OX) Propylene Glycol (UNII: 6DC9Q167V3) Alcohol (UNII: 3K9958V90M) TROLAMINE (UNII: 9O3K93S3TK) Water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:36800-729-01 30 mL in 1 TUBE; Type 0: Not a Combination Product 10/20/2011 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 10/20/2011 Labeler - Top Care (006935977) Registrant - Product Quest Mfg (927768135) Establishment Name Address ID/FEI Business Operations Product Quest Mfg 927768135 manufacture(36800-729) , label(36800-729)