COLD SORE TREATMENT- camphor cream

Cold Sore Treatment by

Drug Labeling and Warnings

Cold Sore Treatment by is a Otc medication manufactured, distributed, or labeled by AAFES/Your Military Exchanges, Ranir LLC, Unicep Packaging LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Benzalkonium Chloride 0.13%

Camphor 3.0%

Purpose

Cold Sore/Fever Blister Treatment/First Aid Antiseptic

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
• first aid to help protect against infection in minor cuts, scrapes, burns, and sores

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

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
• wash hands before and after applying the product
• do not share this product with anyone
• children under 12 years of age: ask a doctor

Other Information

store at room temperature

Inactive Ingredients

alcohol, aloe barbadensis leaf juice, arginine, butylparaben, cetearyl isononanoate, ethylparaben, eucalyptus globulus leaf oil, hexcyldecanol, hexyldecyl laurate, melaleuca alternifolia (tea tree) leaf oil, menthol, methylparaben, ozokerite, phenoxyethanol, poloxamer 407, propylparaben, thymol, tocopheryl nicotinate (vitamin e), zinc chloride

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

COLD SORE TREATMENT 
camphor cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55301-407
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
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.3 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ARGININE (UNII: 94ZLA3W45F)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
CERESIN (UNII: Q1LS2UJO3A)
CETEARYL ISONONANOATE (UNII: P5O01U99NI)
TEA TREE OIL (UNII: VIF565UC2G)
PROPYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: O4446S9CRA)
ETHYLPARABEN (UNII: 14255EXE39)
HEXYLDECANOL (UNII: 151Z7P1317)
CETYL LAURATE (UNII: I19DN3Q5ZP)
MENTHOL (UNII: L7T10EIP3A)
METHYLPARABEN (UNII: A2I8C7HI9T)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLOXAMER 407 (UNII: TUF2IVW3M2)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
EUCALYPTOL (UNII: RV6J6604TK)
THYMOL (UNII: 3J50XA376E)
TOCOPHERYL NICOTINATE, D-.ALPHA. (UNII: WI1J5UCY5C)
ZINC CHLORIDE (UNII: 86Q357L16B)
ALCOHOL (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55301-407-01	1 in 1 PACKAGE	11/04/2014
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	part348	11/04/2014

Labeler - AAFES/Your Military Exchanges (001695568)

Registrant - Ranir LLC (364567615)

Establishment
Name	Address	ID/FEI	Business Operations
Ranir LLC		364567615	relabel(55301-407)

Establishment
Name	Address	ID/FEI	Business Operations
Unicep Packaging LLC		790263909	manufacture(55301-407)