MAXIMUM STRENGTH COLD SORE TREATMENT gel

Maximum Strength Cold Sore Treatment by

Drug Labeling and Warnings

Maximum Strength Cold Sore Treatment by is a Otc medication manufactured, distributed, or labeled by Meijer Distribution Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients Purpose

Camphor 3.00%

Menthol 1.00%

Phenol 1.50%

White Petrolatum 89.20%

PURPOSE

Purpose

Cold sore/fever blister treatment

Cold sore/fever blister treatment

Cold sore/fever blister treatment

Skin Protectant

WHEN USING

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

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.

OTHER SAFETY INFORMATION

Other information store at room temperature

INACTIVE INGREDIENT

Inactive ingredients Eucalyptol, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Thymol,

Tocopheryl Nicotinate

QUESTIONS

Questions or comments?

Call us toll-free at 1-877-242-3234 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.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

at 1-800-222-1222.

INDICATIONS & USAGE

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

DOSAGE & ADMINISTRATION

Apply a small amount of this product to the affected area 1 to 3 times daily

Cold Sore Tube card PDP

Maximum Strength

(Camphor 3.00%, Menthol 1.00%, Phenol 1.50%, White Petrolatum 89.20%)

Cold Sore Treatment

Medicated

Temporary Relief of Pain and Discomfort

Works on Contact

Applied Clear

Phthalate Free**

Paraben Free*

Sulfate Free

With Tea Tree Oil

Cold Sore / Fever Blister treatment & Skin Protectant

NET WT 0.07 OZ ( 2.0 g)

*Free from Methylparaben, Ethylparaben, Propylparaben and Butylparaben

**tested per CPSC-CH-C1001.09.3

DIST. BY MEIJER

DISTRIBUTION, INC.

GRAND RAPIDS, MI 49544

www.meijer.com

INGREDIENTS AND APPEARANCE

MAXIMUM STRENGTH COLD SORE TREATMENT 
maximum strength cold sore treatment gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41250-411
Route of Administration	TOPICAL

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

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

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41250-411-01	2 g in 1 TUBE; Type 0: Not a Combination Product	09/09/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	09/09/2019

Labeler - Meijer Distibution Inc. (006959555)

Registrant - Ranir LLC (364567615)

Establishment
Name	Address	ID/FEI	Business Operations
Accupac, Inc		071609663	manufacture(41250-411) , analysis(41250-411) , label(41250-411)

Establishment
Name	Address	ID/FEI	Business Operations
Ranir LLC		364567615	pack(41250-411) , label(41250-411) , repack(41250-411)