ORALABS COLD SORE TREATMENT- benzocaine ointment

OraLabs Cold Sore Treatment by

Drug Labeling and Warnings

OraLabs Cold Sore Treatment by is a Otc medication manufactured, distributed, or labeled by OraLabs. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

ORALABS COLD SORE TREATMENT 
benzocaine ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63645-162
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	5.00 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63645-162-04	1 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	08/01/2014

Labeler - OraLabs (801824756)

Registrant - OraLabs (801824756)

Establishment
Name	Address	ID/FEI	Business Operations
OraLabs		801824756	MANUFACTURE(63645-162) , LABEL(63645-162)