CAPSADYN- capsaicin cream 
Chorda Pharma, Inc

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Capsadyn

Topical analgesic

Capsaicin 0.25% as Capsaicin palmitate

For the temporary relief of minor aches and pains of muscles and joints associated with arthritis, muscle strains, sprains, bruises, related muscle injuries, and simple backache. Provides penetrating pain relief.

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.

If swallowed, get medical help or contact a Poison Control Center right away.

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.

Butyrospermum parkii (shea) butter, ceteareth-20, cetyl alcohol, cocos nucifera (coconut) oil, ethylhexylglycerin, glycerin, glyceryl stearate, helianthus annuus (sunflower) seed oil, myristyl myristate, phenoxyethanol, polysorbate 20, stearic acid, water.

Carton

CAPSADYN 
capsaicin cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83009-169
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.25 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83009-169-0128 g in 1 JAR; Type 0: Not a Combination Product10/13/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01710/13/2023
Labeler - Chorda Pharma, Inc (099853035)
Registrant - Derma Care Research Labs, LLC (116817470)
Establishment
NameAddressID/FEIBusiness Operations
Derma Care Research Labs, LLC116817470manufacture(83009-169)

Revised: 10/2023
Document Id: 07731045-0d2c-76b7-e063-6294a90af921
Set id: 07731045-0d2b-76b7-e063-6294a90af921
Version: 1
Effective Time: 20231011
 
Chorda Pharma, Inc