Principle Display Panel

Principle Display Panel
SPL v4
SPL
SPL Set ID 8c638c33-a63b-1c6b-e053-2995a90a41f3
Route
TOPICAL
Published
Effective Date 2024-11-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Identifiers & Packaging


Description

Camphor 3.00% Menthol 1.00% Phenol 1.50% White Petrolatum 89.20%


Medication Information

Warnings and Precautions

For external use only: Do not use in the eyes or apply over large areas of the body. In case of deep or puncture wounds, animal bites or serious burns, consult a physician. Allergy alert: Do not use if you are allergic to any of the ingredients in this product.

Indications and Usage

• For treatment of cold sores/fever blisters on the face or lips • Temporarily relieves the symptoms of itching and pain associated with cold sores/fever blisters • Temporarily protects minor cuts, scrapes, burns, and sores • Helps prevent and temporarily protects chapped or cracked skin and lips

Dosage and Administration

• Clean the affected area • Apply a small amount of this product to the affected area 1 to 3 times daily • Rub in gently • May be covered with a sterile bandage • Wash hands before and after applying cream • Do not share this product with anyone • Children under 12 years of age: ask a doctor

Description

Camphor 3.00% Menthol 1.00% Phenol 1.50% White Petrolatum 89.20%

Section 50565-1

If swallowed, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

Section 50566-9

the condition persists or gets worse. Do not use longer than 1 week unless directed by a doctor.

Section 50567-7

avoid contact with eyes. Use only as directed.

Section 51727-6

Eucalyptol, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Thymol, Tocopheryl Nicotinate

Section 51945-4

maximum strength camphor 3.00%, menthol 1.00%, phenol 1.50%, white petrolatum 89.20% cold sore treatment cold sore/fever blister treatment and skin protectant temporary relief of pain and discomfort works on contact applies clear paraben free NET WT 0.07 OZ (2.0 g) apply up to 3 times daily

Section 53413-1

Call us toll-free at 1-800-910-6874 Monday-Friday, 9 a.m. to 5 p.m. EST. Serious side effects associated with use of this product may be reported to this number.

Section 55105-1

Cold sore/fever blister treatment Skin Protectant

Section 55106-9

Camphor 3.00% Menthol 1.00% Phenol 1.50% White Petrolatum 89.20%

Section 60561-8

store at room temperature


Structured Label Content

Indications and Usage (34067-9)

• For treatment of cold sores/fever blisters on the face or lips • Temporarily relieves the symptoms of itching and pain associated with cold sores/fever blisters • Temporarily protects minor cuts, scrapes, burns, and sores • Helps prevent and temporarily protects chapped or cracked skin and lips

Dosage and Administration (34068-7)

• Clean the affected area • Apply a small amount of this product to the affected area 1 to 3 times daily • Rub in gently • May be covered with a sterile bandage • Wash hands before and after applying cream • Do not share this product with anyone • Children under 12 years of age: ask a doctor

Warnings and Precautions (34071-1)

For external use only: Do not use in the eyes or apply over large areas of the body. In case of deep or puncture wounds, animal bites or serious burns, consult a physician. Allergy alert: Do not use if you are allergic to any of the ingredients in this product.

Section 50565-1 (50565-1)

If swallowed, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

Section 50566-9 (50566-9)

the condition persists or gets worse. Do not use longer than 1 week unless directed by a doctor.

Section 50567-7 (50567-7)

avoid contact with eyes. Use only as directed.

Section 51727-6 (51727-6)

Eucalyptol, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Thymol, Tocopheryl Nicotinate

Section 51945-4 (51945-4)

maximum strength camphor 3.00%, menthol 1.00%, phenol 1.50%, white petrolatum 89.20% cold sore treatment cold sore/fever blister treatment and skin protectant temporary relief of pain and discomfort works on contact applies clear paraben free NET WT 0.07 OZ (2.0 g) apply up to 3 times daily

Section 53413-1 (53413-1)

Call us toll-free at 1-800-910-6874 Monday-Friday, 9 a.m. to 5 p.m. EST. Serious side effects associated with use of this product may be reported to this number.

Section 55105-1 (55105-1)

Cold sore/fever blister treatment Skin Protectant

Section 55106-9 (55106-9)

Camphor 3.00% Menthol 1.00% Phenol 1.50% White Petrolatum 89.20%

Section 60561-8 (60561-8)

store at room temperature


Raw Label Data

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