MEDICATED LIP BALM salve

Medicated Lip Balm by

Drug Labeling and Warnings

Medicated Lip Balm by is a Otc medication manufactured, distributed, or labeled by Walgreen Co, Lee Pharmaceuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Camphor, 1.7%

Menthol, 0.7%

Phenol, 0.4%

Purpose

External Analgesic

Uses

• temporarily relieves pain and itching commonly associated with fever blisters and cold sores

Warnings

For external use only

WHEN USING

When using this product keep out of eyes.  Rinse with water to remove.

STOP USE

Stop use and ask a doctor

• if rash occurs
• symptoms last for more than 7 days or clear up and occur agin within a few days

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• adults and children 2 years of age and older, apply to lips not more than 3 to 4 times daily
• children under 2 years of age: ask a doctor

Inactive ingredients

Alum, beeswax, cocoa butter, flavor, lanolin, petrolatum, salicylic acid

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MEDICATED LIP BALM 
medicated lip balm salve

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-6040
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941)	CAMPHOR (NATURAL)	1.7 mg  in 1 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.7 mg  in 1 g
PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV)	PHENOL	0.4 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALUM, POTASSIUM (UNII: 1L24V9R23S)
WHITE WAX (UNII: 7G1J5DA97F)
COCOA BUTTER (UNII: 512OYT1CRR)
LANOLIN (UNII: 7EV65EAW6H)
PETROLATUM (UNII: 4T6H12BN9U)
SALICYLIC ACID (UNII: O414PZ4LPZ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0363-6040-02	2 in 1 BLISTER PACK
1	NDC: 0363-6040-01	7 g in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	10/30/2013

Labeler - Walgreen Co (008965063)

Registrant - Lee Pharmaceuticals (056425432)

Establishment
Name	Address	ID/FEI	Business Operations
Lee Pharmaceuticals		056425432	manufacture(0363-6040)