Label: CAPSADYN- capsaicin cream
- NDC Code(s): 83009-169-01
- Packager: Chorda Pharma, Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 11, 2023
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- Official Label (Printer Friendly)
- PURPOSE
- ACTIVE INGREDIENT
- INDICATIONS & USAGE
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WARNINGS
For external use only.
Do not apply to wounds and damaged skin.
When using this product use only as directed, temporary warming of skin may be experienced after application, avoid contact with eyes or mucous membranes, do not bandage tightly, do not expose the treated area to heat, and avoid activity that may cause perspiration.
Stop use and ask a doctor if condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days.
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Adults and children 18 years of age and older:
apply to affected areas not more than 3-4 times daily, rub in the cream until completely absorbed, the amount used depends on the depth of the pain, typically provides pain relief without any noticeable warming or cooling, wash hands thoroughly with soap and water after applying.
Children under 18 years of age: consult a doctor.
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CAPSADYN
capsaicin creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83009-169 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN 0.25 g in 100 g Inactive Ingredients Ingredient Name Strength POLYSORBATE 80 (UNII: 6OZP39ZG8H) PHENOXYETHANOL (UNII: HIE492ZZ3T) STEARIC ACID (UNII: 4ELV7Z65AP) COCONUT OIL (UNII: Q9L0O73W7L) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) MYRISTYL MYRISTATE (UNII: 4042ZC00DY) SHEA BUTTER (UNII: K49155WL9Y) SUNFLOWER OIL (UNII: 3W1JG795YI) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83009-169-01 28 g in 1 JAR; Type 0: Not a Combination Product 10/13/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M017 10/13/2023 Labeler - Chorda Pharma, Inc (099853035) Registrant - Derma Care Research Labs, LLC (116817470) Establishment Name Address ID/FEI Business Operations Derma Care Research Labs, LLC 116817470 manufacture(83009-169)