Label: CAPSAICIN HP ARTHRITIS PAIN RELIEF- capsaicin cream
- NDC Code(s): 69375-006-60
- Packager: Nationwide Pharmaceutical LLC
- 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 August 4, 2023
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Uses
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Warnings
For external use only
When using this product
- If you are a first time user and think your skin might be sensitive to Capsaicin, test it on a small area first
- rare cases of serious burns have been reported with products of this type
- do not bandage tightly or apply local heat (such as heating pads) to the area of use
- avoid contact with eyes and mucous membranes do not apply to wounds or damaged, broken or irritated skln
- a transient burning sensation may occur upon application but generally disappears in several days
- if severe burning occurs, discontinue use immediately and read inside carton for important Information
- do not expose the area treated with product to heat or direct sunlight do not use al the same time as other topical analgesics
- use only as directed. Read and follow all directions and warnings on this carton
- do not use if you are allergic to capsaicin or chili peppers
- Directions
- STORAGE AND HANDLING
- Inactive ingredients
- Questions: or comments
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 56.6 g Tube Carton
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INGREDIENTS AND APPEARANCE
CAPSAICIN HP ARTHRITIS PAIN RELIEF
capsaicin creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69375-006 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) Isopropyl Myristate (UNII: 0RE8K4LNJS) Cetyl Alcohol (UNII: 936JST6JCN) PEG-40 Stearate (UNII: ECU18C66Q7) Glyceryl Monostearate (UNII: 230OU9XXE4) Sorbitol (UNII: 506T60A25R) PETROLATUM (UNII: 4T6H12BN9U) Water (UNII: 059QF0KO0R) Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69375-006-60 1 in 1 CARTON 08/21/2023 1 56.6 g in 1 TUBE; 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 08/21/2023 Labeler - Nationwide Pharmaceutical LLC (079265801)