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OraLabs Cold Sore Treatment

Medically reviewed on September 4, 2017

Dosage form: ointment
Ingredients: BENZOCAINE 5.00mg in 1g
Labeler: OraLabs
NDC Code: 63645-162

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.

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: 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 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
ORALABS COLD SORE TREATMENT 
benzocaine ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63645-162
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (BENZOCAINE) BENZOCAINE5.00 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
LIGHT MINERAL OIL2.00 mg  in 1 g
DOCOSANOL10 mg  in 1 g
BENZYL ALCOHOL9.00 mg  in 1 g
SUCROSE STEARATE5.00 mg  in 1 g
PROPYLENE GLYCOL4.99 mg  in 1 g
WATER64 mg  in 1 g
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:63645-162-041 g in 1 CONTAINER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/01/2014
Labeler - OraLabs (801824756)
Registrant - OraLabs (801824756)
Establishment
NameAddressID/FEIOperations
OraLabs801824756MANUFACTURE(63645-162), LABEL(63645-162)

 
OraLabs

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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