COLD SORE TREATMENT- camphor cream
Retail Business Services, 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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BPC 407 - Ahold (RBS) – Drug Facts

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

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.

COLD SORE TREATMENT
camphor cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:72476-407
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)
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, UNSPECIFIED FORM (UNII: L7T10EIP3A)
METHYLPARABEN (UNII: A2I8C7HI9T)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:72476-407-01	1 in 1 PACKAGE	03/30/2016	10/05/2021
1		2 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	03/30/2016	10/05/2021

Labeler - Retail Business Services, LLC (967989935)

Revised: 11/2021

Document Id: 0ec3229c-87e6-46a3-8aba-0769dd817c51

Set id: 97422061-5fe9-6a04-e053-2a95a90aff34

Version: 3

Effective Time: 20211124

Retail Business Services, LLC