MAXIMUM STRENGTH COLD SORE TREATMENT gel

United States - English - NLM (National Library of Medicine)

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Active ingredient:
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A), PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U), CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET), PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV)
Available from:
Meijer Distibution Inc.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Purpose Cold sore/fever blister treatment Cold sore/fever blister treatment Cold sore/fever blister treatment Skin Protectant 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
Authorization status:
OTC monograph not final
Authorization number:
41250-411-01

MAXIMUM STRENGTH COLD SORE TREATMENT- maximum strength cold sore

treatment gel

Meijer Distibution Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they

comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Maximum Strength Cold Sore Treatment - Meijer

Active ingredients Purpose

Camphor 3.00%

Menthol 1.00%

Phenol 1.50%

White Petrolatum 89.20%

Purpose

Cold sore/fever blister treatment

Cold sore/fever blister treatment

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.

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 1-877-242-3234 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. 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

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

MAXIMUM STRENGTH COLD SORE TREATMENT

maximum strength cold sore treatment gel

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:41250 -411

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

MENTHO L (UNII: L7T10 EIP3A) (MENTHOL - UNII:L7T10 EIP3A)

MENTHOL

10 mg in 1 g

PETRO LATUM (UNII: 4T6 H12BN9 U) (PETROLATUM - UNII:4T6 H12BN9 U)

PETROLATUM

8 9 2 mg

in 1 g

CAMPHO R ( SYNTHETIC) (UNII: 5TJD8 2A1ET) (CAMPHOR (SYNTHETIC) -

UNII:5TJD8 2A1ET)

CAMPHOR

(SYNTHETIC)

30 mg in 1 g

PHENO L (UNII: 339 NCG44TV) (PHENOL - UNII:339 NCG44TV)

PHENOL

15 mg in 1 g

Inactive Ingredients

Ingredient Name

Stre ng th

TO CO PHERYL NICO TINATE, D-.ALPHA. (UNII: WI1J5UCY5C)

THYMO L (UNII: 3J50 XA376 E)

EUCALYPTO L (UNII: RV6 J6 6 0 4TK)

Meijer Distibution Inc.

MELALEUCA ALTERNIFO LIA LEAF (UNII: G43C5716 2K)

Product Characteristics

Color

white

S core

S hap e

S iz e

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:41250 -411-0 1

2 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

0 9 /0 9 /20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt333E

0 9 /0 9 /20 19

Labeler -

Meijer Distibution Inc. (006959555)

Registrant -

Ranir LLC (364567615)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Accupac, Inc

0 716 0 9 6 6 3

manufacture(41250 -411) , analysis(41250 -411) , label(41250 -411)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Ranir LLC

36 456 76 15

pack(41250 -411) , label(41250 -411) , repack(41250 -411)

Revised: 12/2019

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