Label: RUGBY CAPSAICIN CREAM- capsaicin cream
- NDC Code(s): 0536-1264-56
- Packager: Rugby Laboratories
- 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 June 29, 2023
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- Drug Facts
- Active Ingredient
- Purpose
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Warnings
For external use only: TEST FIRST ON SMALL AREA OF SKIN.
When using this product:
- Use only as directed
- Do not apply to wounds, damaged, broken or irritated sin
- Do not use if you are allergic to capssicum or chili peppers
- Avoid contact with the eyes or mucous membranes
- A slight burning sensation may occur upon application, but generally disappears after several days of use
- If severe burning occurs, discontinue use
- Do not expose the treated area to heat or direct sunlight
- Do not bandage
- Do not use with heating pad
- Stop Use and Ask Doctor
- Keep Out of the Reach of Children
- Uses
- If Pregnant or Breast Feeding
- Directions
- Inactive Ingredients
- Questions
- Other Information
- Packaging
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INGREDIENTS AND APPEARANCE
RUGBY CAPSAICIN CREAM
capsaicin creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0536-1264 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 ALOE VERA LEAF (UNII: ZY81Z83H0X) ETHYLPARABEN (UNII: 14255EXE39) MINERAL OIL (UNII: T5L8T28FGP) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PETROLATUM (UNII: 4T6H12BN9U) LAURETH-15 (UNII: 002FR4N8OV) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0536-1264-56 1 in 1 BOX 02/17/2020 1 42.5 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 02/17/2020 Labeler - Rugby Laboratories (079246066) Registrant - Trifecta Pharmaceuticals USA LLC (079424163)