WALGREENS COLD SORE TREATMENT- benzocaine ointment 
Walgreens

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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Drug Facts

Active ingredient

Benzocaine

Purpose

Cold Sore/Fever Blister Treatment/Pain Reliever

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

Uses

For treatment of cold sores/fever blisters on the face and lips

Warnings

For external use only: Allergy Alert: Do not use this product if you have a history of allergy to local anesthetics such as procaine, butocaine, benzocaine, or other “caine: anesthetics.

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.

When using this product avoid contact with eyes. Use only as directed.

Stop use and ask a doctor if the condition gets worse. Do not use longer than 1 week unless directed by a doctor.

Directions

Clean the affected

Adults and children 2 years of age and older: Apply to affected area not more than 4 times daily

Children under 2 years of age: consult a physician

Rub in gently – Applies clear

Wash hands before and after applying cream

Do not share this product with anyone

Inactive Ingredients

Benzyl Alcohol, Docosanol, Mineral Oil, Propylene Glycol, Sucrose Stearate, Tocopherol, Water.

Package/Label Principal Display Panel

Well at Walgreens Cold Sore Treatment
WALGREENS COLD SORE TREATMENT 
benzocaine ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-3191
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE5.00 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
LIGHT MINERAL OIL (UNII: N6K5787QVP) 2.00 mg  in 1 g
DOCOSANOL (UNII: 9G1OE216XY) 10 mg  in 1 g
BENZYL ALCOHOL (UNII: LKG8494WBH) 9.00 mg  in 1 g
SUCROSE STEARATE (UNII: 274KW0O50M) 5.00 mg  in 1 g
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 4.99 mg  in 1 g
WATER (UNII: 059QF0KO0R) 64 mg  in 1 g
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0363-3191-011 g in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34804/01/2015
Labeler - Walgreens (008965063)
Registrant - Walgreens (008965063)
Establishment
NameAddressID/FEIBusiness Operations
OraLabs801824756MANUFACTURE(0363-3191) , LABEL(0363-3191)

Revised: 4/2015
Document Id: 67d18f83-eb96-42ae-90f4-883f3bca0b77
Set id: 67d18f83-eb96-42ae-90f4-883f3bca0b77
Version: 1
Effective Time: 20150401
 
Walgreens