ABRIDGE COLD SORE TREATMENT- camphor cream 
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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BPC 407 - Abridge

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.

AbridgeColdSoreCard-46899.jpg
ABRIDGE COLD SORE TREATMENT 
camphor cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66923-407
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)30 mg  in 1 g
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
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, UNSPECIFIED FORM (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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66923-407-011 in 1 PACKAGE04/05/201305/12/2021
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 finalpart34804/05/201305/12/2021
Labeler - Ranir LLC (364567615)

Revised: 2/2021
 
Ranir LLC