Initial Drug Listing - Plantar Fasciitis Cream

Initial Drug Listing - Plantar Fasciitis Cream
SPL v1
SPL
SPL Set ID 388f33c2-2bdf-ded8-e063-6294a90aeeac
Route
TOPICAL
Published
Effective Date 2025-07-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Camphor, (-)- (50 mg)
Inactive Ingredients
Water Angelica Sinensis Root Taraxacum Officinale Safflower Clove Cinnamomum Cassia Twig Wormwood Stearic Acid Glyceryl Monostearate Methylparaben Phenoxyethanol Borneol Glycerin Ligusticum Wallichii Root Black Pepper Cinnamon

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-07-18
Description

Camphor 5%

Medication Information

Warnings and Precautions

For external use, do not take orally or get into eyes

Indications and Usage

- helps relieve minor foot and heel discomfort such as: arch tightness, stiffness, soreness linked to plantar fasciitis, ired or overused feet

Dosage and Administration
  • Clean the affected area before use.
  • Take an appropriate amount of this product and apply it evenly on the affected area, massage until completely absorbed.
  • Adults and children 12+, apply to affected area up to 3-4 times daily.
  • Children under 12, ask a doctor.
Description

Camphor 5%

Section 50565-1

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

Section 50566-9

If you experience an allergic reaction, discontinue use and consult a physician

Section 50567-7
  • if there are abnormalities such as skin rashes and allergies, do not scratch.
  • Avoid contact with eyes and mucous membranes
Section 50570-1

Do not use on open wounds.

Section 51727-6

Water, Glycerin, Angelica Sinensis Root, Taraxacum Officinale, Safflower, Black Pepper, Clove, Cinnamon, Cinnamomum Cassia Twig, Ligusticum Wallichii Root, Wormwood, Stearic Acid, Glyceryl Monostearate, Methylparaben, Phenoxyethanol, Borneol

Section 51945-4

Section 53413-1

please contact us at: [email protected]

Section 55105-1

Topical Analgesic

Section 55106-9

Camphor 5%

Section 60561-8

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

Structured Label Content

Indications and Usage (34067-9)

- helps relieve minor foot and heel discomfort such as: arch tightness, stiffness, soreness linked to plantar fasciitis, ired or overused feet

Dosage and Administration (34068-7)
  • Clean the affected area before use.
  • Take an appropriate amount of this product and apply it evenly on the affected area, massage until completely absorbed.
  • Adults and children 12+, apply to affected area up to 3-4 times daily.
  • Children under 12, ask a doctor.
Warnings and Precautions (34071-1)

For external use, do not take orally or get into eyes

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

If you experience an allergic reaction, discontinue use and consult a physician

Section 50567-7 (50567-7)
  • if there are abnormalities such as skin rashes and allergies, do not scratch.
  • Avoid contact with eyes and mucous membranes
Section 50570-1 (50570-1)

Do not use on open wounds.

Section 51727-6 (51727-6)

Water, Glycerin, Angelica Sinensis Root, Taraxacum Officinale, Safflower, Black Pepper, Clove, Cinnamon, Cinnamomum Cassia Twig, Ligusticum Wallichii Root, Wormwood, Stearic Acid, Glyceryl Monostearate, Methylparaben, Phenoxyethanol, Borneol

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

please contact us at: [email protected]

Section 55105-1 (55105-1)

Topical Analgesic

Section 55106-9 (55106-9)

Camphor 5%

Section 60561-8 (60561-8)

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:32.939818 · Updated: 2026-03-14T23:09:23.715399