Drug Facts

Drug Facts
SPL v6
SPL
SPL Set ID f74db6e0-853a-4eb3-a4b5-9da2cd3d95cf
Route
TOPICAL
Published
Effective Date 2024-11-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Capsaicin (0.025 g)
Inactive Ingredients
Hydrogenated Polydecene (550 Mw) Pentaerythritol Tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) Liquid Petroleum Styrene/acrylamide Copolymer (mw 500000)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-09-18

Description

Active ingredient Capsaicin 0.025%


Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

Uses

For the temporary relief of minor aches and pains of muscles and joints due to:

simple backache

arthritis

strains

bruises

sprains

Dosage and 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

Description

Active ingredient Capsaicin 0.025%

Section 34084-4

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

Section 44425-7

Other information

keep patches tightly closed in the zip-lock pouch

avoid excessive heat

Section 50565-1

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

Section 50566-9

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

Section 50567-7

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

Section 50568-5

Ask a doctor or pharmacist before use if you have

any concerns about using this product

Section 50570-1

Do not use

on irritated or damaged skin on wounds

Section 51727-6

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

Section 51945-4

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)

Section 53413-1

Questions or comments? (888) 221-3496 M-F 9 am to 5 pm

you may also report serious side effects to this phone number

Section 55105-1

Purpose

External analgesic

Section 55106-9

Active ingredient

Capsaicin 0.025%


Structured Label Content

Indications and Usage (34067-9)

Uses

For the temporary relief of minor aches and pains of muscles and joints due to:

simple backache

arthritis

strains

bruises

sprains

Dosage and Administration (34068-7)

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 and Precautions (34071-1)

Warnings

For external use only

Section 34084-4 (34084-4)

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

Section 44425-7 (44425-7)

Other information

keep patches tightly closed in the zip-lock pouch

avoid excessive heat

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

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

Section 50567-7 (50567-7)

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

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you have

any concerns about using this product

Section 50570-1 (50570-1)

Do not use

on irritated or damaged skin on wounds

Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

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)

Section 53413-1 (53413-1)

Questions or comments? (888) 221-3496 M-F 9 am to 5 pm

you may also report serious side effects to this phone number

Section 55105-1 (55105-1)

Purpose

External analgesic

Section 55106-9 (55106-9)

Active ingredient

Capsaicin 0.025%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)