Walgreens Cold Sore Treatment: Package Insert and Label Information

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.

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
(click image for full-size original)
WALGREENS COLD SORE TREATMENT
benzocaine ointment
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-3191
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOCAINE (BENZOCAINE) BENZOCAINE 5.00 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
LIGHT MINERAL OIL 2.00 mg in 1 g
DOCOSANOL 10 mg in 1 g
BENZYL ALCOHOL 9.00 mg in 1 g
SUCROSE STEARATE 5.00 mg in 1 g
PROPYLENE GLYCOL 4.99 mg in 1 g
WATER 64 mg in 1 g
Product Characteristics
Color WHITE Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0363-3191-01 1 g in 1 CONTAINER None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 04/01/2015
Labeler — Walgreens (008965063)
Registrant — Walgreens (008965063)
Establishment
Name Address ID/FEI Operations
OraLabs 801824756 MANUFACTURE (0363-3191), LABEL (0363-3191)

Revised: 04/2015 Walgreens

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