MEDICATED LIP BALM- medicated lip balm salve 
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.

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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

Label

Card

MEDICATED LIP BALM 
medicated lip balm salve
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-6040
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)1.7 mg  in 1 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.7 mg  in 1 g
PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV) PHENOL0.4 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALUM, POTASSIUM (UNII: 1L24V9R23S)  
WHITE WAX (UNII: 7G1J5DA97F)  
COCOA BUTTER (UNII: 512OYT1CRR)  
LANOLIN (UNII: 7EV65EAW6H)  
PETROLATUM (UNII: 4T6H12BN9U)  
SALICYLIC ACID (UNII: O414PZ4LPZ)  
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
Document Id: 9633b49b-9152-4bdb-9c2e-e6b39b92006a
Set id: 9e3077f7-4181-4e35-8ec7-2065f555a7b8
Version: 3
Effective Time: 20131115
 
Walgreen Co