MEDICATED LIP BALM- camphor (natural), menthol and phenol 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 Type HUMAN OTC DRUG Item Code (Source) NDC:0363-6040
Route of Administration TOPICAL DEA Schedule     
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)

Revised: 11/2013
Document Id: 9633b49b-9152-4bdb-9c2e-e6b39b92006a
Set id: 9e3077f7-4181-4e35-8ec7-2065f555a7b8
Version: 3
Effective Time: 20131115
 
Walgreen Co