TOPCARE COLD SORE TREATMENT- camphor cream

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, Ranir LLC, Unicep Packaging LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

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
• 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

alcohol, aloe barbadensis leaf juice, arginine, butylparaben, cetearyl isononanoate, dipropylene glycol dicaprylate/dicaprate, ethylparaben, eucalyptus globulus leaf oil, hexyl decyl laurate, hexyldecanole, 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 1-888-423-0139

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TOPCARE COLD SORE TREATMENT 
camphor cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-407
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.3 mg  in 1 g
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	30 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ARGININE (UNII: 94ZLA3W45F)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
CERESIN (UNII: Q1LS2UJO3A)
CETEARYL ISONONANOATE (UNII: P5O01U99NI)
EUCALYPTOL (UNII: RV6J6604TK)
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)
TEA TREE OIL (UNII: VIF565UC2G)
THYMOL (UNII: 3J50XA376E)
TOCOPHERYL NICOTINATE, D-.ALPHA. (UNII: WI1J5UCY5C)
ZINC CHLORIDE (UNII: 86Q357L16B)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-407-01	1 in 1 PACKAGE	04/10/2013
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	04/10/2013

Labeler - Topco Associates LLC (006935977)

Registrant - Ranir LLC (364567615)

Establishment
Name	Address	ID/FEI	Business Operations
Ranir LLC		364567615	repack(36800-407) , relabel(36800-407)

Establishment
Name	Address	ID/FEI	Business Operations
Unicep Packaging LLC		790263909	manufacture(36800-407)