PREFERRED PLUS MEDICATED LIP BALM- medicated lip balm stick

PREFERRED PLUS MEDICATED LIP BALM by

Drug Labeling and Warnings

PREFERRED PLUS MEDICATED LIP BALM by is a Otc medication manufactured, distributed, or labeled by Kinray, Lee Pharmaceuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

• Camphor, 1.7%
• Menthol, 0.7%
• Phenol, 0.4%

Purpose

• Anti-infective
• Anti-itching
• Anesthetic

Uses

• Temporarily relieves pain and itching commonly associated with fever blisters and cold sores.
• Helps prevent dry, chapped, sun and wind burned lips.

Warnings

• For external use only
• Keep out of eyes

STOP USE

• Stop if skin rash occurs
• If irritation or rash persists, consult a physician

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

Directions

• Apply generously as needed
• Children under 6 months of age:  Consult a doctor

INACTIVE INGREDIENT

Alum, Beeswax, Cocoa Butter, Flavor, Lanolin, Petrolatum, Salicylic Acid

PRINCIPAL DISPLAY PANEL

Preferred Plus

Lip Balm Medicated

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PRINCIPAL DISPLAY PANEL

Preferred Plus

Lip Balm Medicated

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INGREDIENTS AND APPEARANCE

PREFERRED PLUS MEDICATED LIP BALM 
medicated lip balm stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61715-051
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	17 mg  in 1 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	7 mg  in 1 g
PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV)	PHENOL	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: 61715-051-94	2 in 1 BLISTER PACK
1	NDC: 61715-051-93	4.25 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		02/28/2007

Labeler - Kinray (012574513)

Registrant - Lee Pharmaceuticals (056425432)

Establishment
Name	Address	ID/FEI	Business Operations
Kinray		012574513	label(61715-051)

Establishment
Name	Address	ID/FEI	Business Operations
Lee Pharmaceuticals		056425432	manufacture(61715-051) , pack(61715-051)