Label: NOBLEAID CAPSAID- capsaicin cream
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Contains inactivated NDC Code(s)
NDC Code(s): 81533-100-15, 81533-100-99 - Packager: Noble OTC 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 October 7, 2021
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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WARNINGS
Warnings
For external use only
Do not use
- on wounds or damaged skin
- with a heating pad
- if you are allergic to capsicum or chili peppers
When using this product
- avoid contact with the eyes and mucus membranes
- a transient burning sensation may occur upon application but generally disappears in a few days
- do not bandage tightly
- do not apply heat to treated area
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
NOBLEAID CAPSAID
capsaicin creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81533-100 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 ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) PETROLATUM (UNII: 4T6H12BN9U) BENZYL ALCOHOL (UNII: LKG8494WBH) CETYL ALCOHOL (UNII: 936JST6JCN) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) SORBITOL (UNII: 506T60A25R) WATER (UNII: 059QF0KO0R) POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81533-100-15 1 in 1 CARTON 08/31/2021 1 42.5 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:81533-100-99 108000 g in 1 DRUM; Type 0: Not a Combination Product 10/07/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 08/31/2021 Labeler - Noble OTC LLC (041836435)