72937-019-03

72937-019-03
SPL v1
SPL
SPL Set ID 45048936-f3c9-25f7-e063-6394a90ac4a9
Route
TOPICAL
Published
Effective Date 2025-12-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Camphor (synthetic) (4 g)
Inactive Ingredients
Water Ceteareth-25 Salicylic Acid Fd&c Yellow No. 6 Carbomer 940 Cannabis Sativa Seed Oil Calendula Officinalis Flower Benzyl Alcohol Sorbic Acid Sodium Hydroxide Methyl Salicylate Alcohol Medium-chain Triglycerides Glycerin

Identifiers & Packaging

Pill Appearance
Color: orange
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-12-02

Description

Camphor ………………………………...…………………………….…. 4%


Medication Information

Warnings and Precautions

• For external use only. • Ask a doctor

before use if you have redness over affected area.

Description

Camphor ………………………………...…………………………….…. 4%

Use

Aid for temporary local relief of minor pain in muscles and joints.

Section 50565-1

If swallowed, get medical help, or contact a Poison Control Center right away.

Section 50567-7
  • Avoid contact with the eyes or mucous membranes.
  • Do not apply to wounds or damaged skin.
  • Do not apply to the irritated skin or if excessive irritation develops.
  • Do not bandage.
  • Do not use with heating pad or device.
  • Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days, or clear up and occur again within a few days.
Section 51727-6

Water (Aqua), Alcohol Denat, Ceteareth-25, Glycerin, Caprylic/Capric Triglyceride, Calendula Officinalis Extract, Cannabis Sativa Seed Oil, Carbomer, Sodium Hydroxide, Methyl Salicylate, Benzyl Alcohol, Salicylic Acid, Sorbic Acid, FD&C Yellow #6 (CI 15985).

Section 53414-9

Ask a health professional before use.

Section 55105-1

Topical Analgesic

Section 55106-9

Camphor ………………………………...…………………………….…. 4%

Section 60561-8

Store tightly closed in a dry place at controlled room temperature between 59°F-86° F (15°C-30° C).

Directions

Adults and Children over 12 years of age

● Apply a small amount on the affected area.

● Massage in circular motion, let set for a few seconds.

● Repeat as necessary, but no more than 3 to 4 times daily.

Children under 12 years of age: Do not use, consult a doctor

Questions Or Comments?

Contact us +1 (888) 367-4916

Sunset Heating Pain Relief Roll On


Structured Label Content

Use (USE)

Aid for temporary local relief of minor pain in muscles and joints.

Warnings and Precautions (34071-1)

• For external use only. • Ask a doctor

before use if you have redness over affected area.

Section 50565-1 (50565-1)

If swallowed, get medical help, or contact a Poison Control Center right away.

Section 50567-7 (50567-7)
  • Avoid contact with the eyes or mucous membranes.
  • Do not apply to wounds or damaged skin.
  • Do not apply to the irritated skin or if excessive irritation develops.
  • Do not bandage.
  • Do not use with heating pad or device.
  • Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days, or clear up and occur again within a few days.
Section 51727-6 (51727-6)

Water (Aqua), Alcohol Denat, Ceteareth-25, Glycerin, Caprylic/Capric Triglyceride, Calendula Officinalis Extract, Cannabis Sativa Seed Oil, Carbomer, Sodium Hydroxide, Methyl Salicylate, Benzyl Alcohol, Salicylic Acid, Sorbic Acid, FD&C Yellow #6 (CI 15985).

Section 53414-9 (53414-9)

Ask a health professional before use.

Section 55105-1 (55105-1)

Topical Analgesic

Section 55106-9 (55106-9)

Camphor ………………………………...…………………………….…. 4%

Section 60561-8 (60561-8)

Store tightly closed in a dry place at controlled room temperature between 59°F-86° F (15°C-30° C).

Directions (DIRECTIONS)

Adults and Children over 12 years of age

● Apply a small amount on the affected area.

● Massage in circular motion, let set for a few seconds.

● Repeat as necessary, but no more than 3 to 4 times daily.

Children under 12 years of age: Do not use, consult a doctor

Questions Or Comments? (QUESTIONS OR COMMENTS?)

Contact us +1 (888) 367-4916

Sunset Heating Pain Relief Roll On (SUNSET HEATING PAIN RELIEF ROLL-ON)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)