Label: EXTRA STRENGTH PAIN RELIEVER- capsaicin and menthol, unspecified form cream
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Contains inactivated NDC Code(s)
NDC Code(s): 59092-002-01 - Packager: HPI Health Products Inc.
- 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 October 30, 2014
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
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Warnings
- For external use only.
When using this product
- use only as directed
- do not bandage
- do not use with a heating pad
- avoid contact with eyes and mucous membranes
- do not apply to wounds or 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
- do not expose the area treated with product to heat or direct sunlight
- do not use if you are allergic to capsaicin or chili peppers
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 57 mL Bottle Box
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INGREDIENTS AND APPEARANCE
EXTRA STRENGTH PAIN RELIEVER
capsaicin and menthol, unspecified form creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59092-002 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength capsaicin (UNII: S07O44R1ZM) (capsaicin - UNII:S07O44R1ZM) capsaicin 0.35 mg in 1 mL menthol, unspecified form (UNII: L7T10EIP3A) (menthol, unspecified form - UNII:L7T10EIP3A) menthol, unspecified form 30 mg in 1 mL Inactive Ingredients Ingredient Name Strength carbomer interpolymer type A (allyl sucrose crosslinked) (UNII: 59TL3WG5CO) alcohol (UNII: 3K9958V90M) diazolidinyl urea (UNII: H5RIZ3MPW4) trolamine (UNII: 9O3K93S3TK) water (UNII: 059QF0KO0R) Product Characteristics Color BROWN Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59092-002-01 1 in 1 BOX 1 57 mL in 1 BOTTLE, WITH APPLICATOR; 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 12/01/2014 Labeler - HPI Health Products Inc. (202932864)