Solstice Capsaicin Patch Hot CAPSAICIN MADISON ONE ACME INC FDA Approved Uses For the temporary relief of minor aches and pains of muscles and joints due to: simple backache arthritis strains bruises sprains
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Substance Capsaicin
Route
TOPICAL
Applications
M017

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient Capsaicin 0.025%
Inactive Ingredients
Inactive ingredients hydrogenated poly pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate petroleum and styrene/isoprene copolymer.
Strengths
0.025 %
Quantities
01 count 03 count
Treats Conditions
Uses For The Temporary Relief Of Minor Aches And Pains Of Muscles And Joints Due To Simple Backache Arthritis Strains Bruises Sprains

Identifiers & Packaging

Container Type UNKNOWN
UNII
S07O44R1ZM
Packaging

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

Package Descriptions
  • 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

Overview

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

Indications & Usage

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

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

Warnings & Precautions
Warnings For external use only
Adverse Reactions

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

Purpose

Purpose External analgesic

Do Not Use

Do not use on irritated or damaged skin on wounds

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 & Ask a Doctor

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

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.

Storage & Handling

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

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


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