SOLSTICE CAPSAICIN PATCH HOT- capsaicin patch

Solstice Capsaicin Patch Hot by

Drug Labeling and Warnings

Solstice Capsaicin Patch Hot by is a Otc medication manufactured, distributed, or labeled by MADISON ONE ACME INC, Foshan Aqua Gel Biotech Co., Ltd.,. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient
Capsaicin 0.025%

PURPOSE

Purpose
External analgesic

INDICATIONS & USAGE

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

WARNINGS

Warnings
For external use only

DO NOT USE

Do not use
on irritated or damaged skin on wounds

ASK DOCTOR/PHARMACIST

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

WHEN USING

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

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

ADVERSE REACTIONS

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

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

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

STORAGE AND HANDLING

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

INACTIVE INGREDIENT

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

QUESTIONS

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

PRINCIPAL DISPLAY PANEL

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)

PRINCIPAL DISPLAY PANEL

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)

INGREDIENTS AND APPEARANCE

SOLSTICE CAPSAICIN PATCH HOT 
capsaicin patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55614-410
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	0.025 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55614-410-01	1 in 1 POUCH	09/18/2019
1		9 g in 1 PATCH; Type 0: Not a Combination Product
2	NDC: 55614-410-03	3 in 1 POUCH	09/18/2019
2		9 g in 1 PATCH; 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	09/18/2019

Labeler - MADISON ONE ACME INC (096196758)

Establishment
Name	Address	ID/FEI	Business Operations
Foshan Aqua Gel Biotech Co., Ltd.,		529128763	manufacture(55614-410)