MEDICATED LIP BALM- camphor (natural), menthol and phenol stick 
Walgreen Co

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 ingredients

Camphor, 1.7%

Menthol, 0.7%

Phenol, 0.4%

Purpose

External Analgesic

Uses

Warnings

For external use only

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

Stop use and ask a doctor

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

Directions

Inactive ingredients

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

Card

Label

MEDICATED LIP BALM 
medicated lip balm stick stick
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0363-6080
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:0363-6080-022 in 1 BLISTER PACK
1NDC:0363-6080-014 g in 1 CONTAINER
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(0363-6080)

Revised: 11/2013
Document Id: 6a82dba6-f36e-448c-af67-e98bb33f6da8
Set id: 0bb75602-7eb1-4d4a-9271-c7f84ff552f7
Version: 2
Effective Time: 20131115
 
Walgreen Co