Drug Facts

Drug Facts
SPL v5
SPL
SPL Set ID 1388ab3a-c26f-427d-898d-0d88411a5fba
Route
TOPICAL
Published
Effective Date 2025-11-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Camphor (synthetic) (3.1 g) Menthol (6 g) Salicylic Acid (10 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 2019-07-29

Description

Active ingredient Camphor 3.1% Menthol 6.0% Methyl salicylate 10.0%


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 3 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 3 years of age: consult your physician
Description

Active ingredient Camphor 3.1% Menthol 6.0% Methyl salicylate 10.0%

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 Pain Relieving Patch

Large

Camphor 3.1%, Menthol 6.0%, Methyl Salicylate 10%

NDC 55614-310-06

6 Patches, Each Patch 5.67 in x 3.62 in (14.4 cm x 9.2 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

External analgesic

External analgesic

Section 55106-9

Active ingredient

Camphor 3.1%

Menthol 6.0%

Methyl salicylate 10.0%


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 3 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 3 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 Pain Relieving Patch

Large

Camphor 3.1%, Menthol 6.0%, Methyl Salicylate 10%

NDC 55614-310-06

6 Patches, Each Patch 5.67 in x 3.62 in (14.4 cm x 9.2 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

External analgesic

External analgesic

Section 55106-9 (55106-9)

Active ingredient

Camphor 3.1%

Menthol 6.0%

Methyl salicylate 10.0%


Advanced Ingredient Data


Raw Label Data

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