Ranir Maximum Strength Cold Sore Treatment (never marketed)

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 Ranir LLC, Accupack Midwest. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

MAXIMUM STRENGTH COLD SORE TREATMENT- maximum strength cold sore treatment gel 
Ranir LLC

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.

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Ranir Maximum Strength Cold Sore Treatment (never marketed)

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

Temporary Relief of Pain and Discomfort!

  • Works on Contact
  • Applied Clear

Phalate Free**

Sulfate Free

Paraben Free*

With Tea Tree Oil

Medicated

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

Distributed by:

Ranir LLC

4701 East Paris Ave SE

Grand Rapids, MI 49512

PDP

MAXIMUM STRENGTH COLD SORE TREATMENT 
maximum strength cold sore treatment gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 66923-412
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10 mg  in 1 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM892 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) PHENOL15 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
TOCOPHERYL NICOTINATE, D-.ALPHA. (UNII: WI1J5UCY5C)  
THYMOL (UNII: 3J50XA376E)  
EUCALYPTOL (UNII: RV6J6604TK)  
MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 66923-412-021 in 1 PACKAGE06/27/201906/27/2019
12 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E06/27/201906/27/2019
Labeler - Ranir LLC (364567615)
Registrant - Ranir LLC (364567615)
Establishment
NameAddressID/FEIBusiness Operations
Accupack Midwest139637433manufacture(66923-412) , analysis(66923-412) , label(66923-412)
Establishment
NameAddressID/FEIBusiness Operations
Ranir LLC364567615pack(66923-412) , label(66923-412)

Revised: 11/2019
 
Ranir LLC