SOLSTICE CAPSAICIN PATCH HOT- capsaicin patch

United States - English - NLM (National Library of Medicine)

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Active ingredient:
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)
Available from:
MADISON ONE ACME INC
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
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 Do not use on irritated or damaged skin on wounds 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
Authorization status:
OTC monograph not final
Authorization number:
55614-410-01, 55614-410-03

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.

----------

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)

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)

SOLSTICE CAPSAICIN PATCH HOT

capsaicin patch

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:556 14-410

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

CAPSAICIN (UNII: S0 7O44R1ZM) (CAPSAICIN - UNII:S0 7O44R1ZM)

CAPSAICIN

0 .0 25 g in 10 0 g

Inactive Ingredients

Ingredient Name

Stre ng th

HYDRO GENATED PO LYDECENE ( 550 MW) (UNII: U333RI6 EB7)

PENTAERYTHRITO L TETRAKIS( 3 -( 3 ,5-DI-TERT-BUTYL-4 -HYDRO XYPHENYL) PRO PIO NATE) (UNII:

255PIF6 2MS)

LIQ UID PETRO LEUM (UNII: 6 ZAE7X6 8 8 J)

STYRENE/ACRYLAMIDE CO PO LYMER ( MW 50 0 0 0 0 ) (UNII: 5Z4DPO246 A)

MADISON ONE ACME INC

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:556 14-410 -0 1

1 in 1 POUCH

0 9 /18 /20 19

1

9 g in 1 PATCH; Type 0 : No t a Co mbinatio n Pro duct

2

NDC:556 14-410 -0 3

3 in 1 POUCH

0 9 /18 /20 19

2

9 g in 1 PATCH; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt348

0 9 /18 /20 19

Labeler -

MADISON ONE ACME INC (096196758)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Fo shan Aqua Gel Bio tech Co ., Ltd.,

529 128 76 3

ma nufa c ture (556 14-410 )

Revised: 12/2019

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