TOPCARE COLD SORE TREATMENT- camphor, menthol, phenol, white petrolatum gel

Topcare Cold Sore Treatment by

Drug Labeling and Warnings

Topcare Cold Sore Treatment by is a Otc medication manufactured, distributed, or labeled by Topco Associates LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Camphor 3.00%

Menthol 1.00%

Phenol 1.50%

White Petrolatum 89.20%

Purpose

Cold sore/fever blister treatment

Skin Protectant

Uses

• 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

Warnings

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.

When using this product

avoid contact with eyes. Use only as directed.

Stop use and consult a doctor if

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

Keep out of reach of children.

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

Directions

• 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

Other information

store at room temperature

Inactive ingredients

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

Questions or comments?

Call us toll-free at 1-888-423-0139.

Serious side effects associated with use of this product may be reported to this number.

Package/Label Principal Display Panel

MAXIMUM STRENGTH

CAMPHOR 3.00%, MENTHOL 1.00%, PHENOL 1.50%, WHITE PETROLATUM 89.20%

Cold Sore Treatment

Cold Sore/Fever Blister Treatment & Skin Protectant

Temporary Relief of Pain & Discomfort

Works on Contact

Applies Clear

WITH TEA TREE OIL

OUR PHARMACISTS RECOMMEND

PARABEN FREE

PHTHALATE FREE

SULFATE FREE

NET WT 0.07 FL OZ (2.0 g)

INGREDIENTS AND APPEARANCE

TOPCARE COLD SORE TREATMENT 
camphor, menthol, phenol, white petrolatum gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-418
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	30 mg  in 1 g
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	10 mg  in 1 g
PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV)	PHENOL	15 mg  in 1 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	892 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
EUCALYPTOL (UNII: RV6J6604TK)
MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)
THYMOL (UNII: 3J50XA376E)
TOCOPHERYL NICOTINATE, D-.ALPHA. (UNII: WI1J5UCY5C)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-418-01	1 in 1 PACKAGE	03/09/2020
1		2 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	03/09/2020

Labeler - Topco Associates LLC (006935977)