SOLSTICE CAPSAICIN PATCH HOT- capsaicin patch 
MADISON ONE ACME INC

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.

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Drug Facts

Active ingredient
Capsaicin 0.025%

Purpose
External analgesic

Uses
For the temporary relief of minor aches and pains of muscles and joints due to:
simple backache
arthritis
strains
bruises
sprains

Warnings
For external use only

Do not use
on irritated or damaged skin on wounds

Ask a doctor or pharmacist before use if you have
any concerns about using this product

When using this product
avoid contact with the eyes or mucous membranes

do not bandage tightly

do not apply heat to the area in the form of heating pads, hot water bottles, or lamps (doing so increases the risk of serious burns)

avoid placing on extremely hairy areas of skin to avoid irritation upon removing the patch

Stop use and ask a doctor if
condition worsens

symptoms persist for more than 7 days

symptoms clear up and occur again within a few days

excessive irritation of the skin develops

nausea, vomiting, abdominal discomfort, diarrhea, or skin rash occurs

you feel actual pain or experience blistering or burning after application (it is normal to feel a warming or cooling sensation)

when using for pain of arthritis:
   pain persists for more than 10 days
   redness is present
   in conditions affecting children under 12 years of age

Report any unexpected side effects from the use of this product to the FDA MedWatch Program

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions
adults and children 12 years of age and older:
   clean and dry affected area
   remove the protective film from the patch
   apply patch to affected area not more than 3 to 4 times daily
   remove patch from the skin after at most 8-hour application
   wet patch with warm water before removing from the skin

children under 12 years of age: consult your physician

Other information
keep patches tightly closed in the zip-lock pouch
avoid excessive heat

Inactive ingredientshydrogenated poly, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, petroleum, and styrene/isoprene copolymer.

Questions or comments?(888) 221-3496 M-F 9 am to 5 pm
you may also report serious side effects to this phone number

Solstice Capsaicin Patch Hot

Capsaicin 0.025%

NDC 55614-410-01

1 Patches, Each Patch 5.12 in x 7.09 in (13 cm x 18 cm)
IMAGE OF 1 PATCH POUCH

Solstice Capsaicin Patch Hot

Capsaicin 0.025%

NDC 55614-410-03

3 Patches, Each Patch 5.12 in x 7.09 in (13 cm x 18 cm)
IMAGE OF 3 PATCH POUCH

SOLSTICE CAPSAICIN PATCH HOT 
capsaicin patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55614-410
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.025 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)  
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
LIQUID PETROLEUM (UNII: 6ZAE7X688J)  
STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55614-410-011 in 1 POUCH09/18/2019
19 g in 1 PATCH; Type 0: Not a Combination Product
2NDC:55614-410-033 in 1 POUCH09/18/2019
29 g in 1 PATCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34809/18/2019
Labeler - MADISON ONE ACME INC (096196758)
Establishment
NameAddressID/FEIBusiness Operations
Foshan Aqua Gel Biotech Co., Ltd.,529128763manufacture(55614-410)

Revised: 11/2022
Document Id: 452cd1b1-cbd7-4d42-80cc-f0da98635503
Set id: f74db6e0-853a-4eb3-a4b5-9da2cd3d95cf
Version: 4
Effective Time: 20221103
 
MADISON ONE ACME INC