Your browser does not support JavaScript! MEDICATED LIP BALM SALVE [WALGREEN CO]
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MEDICATED LIP BALM salve
[Walgreen Co]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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 Label Sections

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

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. 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

Label

Card

MEDICATED LIP BALM 
medicated lip balm salve
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0363-6040
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (NATURAL) (CAMPHOR (NATURAL)) CAMPHOR (NATURAL)1.7 mg  in 1 g
MENTHOL (MENTHOL) MENTHOL0.7 mg  in 1 g
PHENOL (PHENOL) PHENOL0.4 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALUM, POTASSIUM 
WHITE WAX 
COCOA BUTTER 
LANOLIN 
PETROLATUM 
SALICYLIC ACID 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0363-6040-022 in 1 BLISTER PACK
1NDC:0363-6040-017 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34810/30/2013
Labeler - Walgreen Co (008965063)
Registrant - Lee Pharmaceuticals (056425432)
Establishment
NameAddressID/FEIBusiness Operations
Lee Pharmaceuticals056425432manufacture(0363-6040)

Revised: 11/2013
 
Walgreen Co

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