CARMEX ORIGINAL LIP BALM EXTERNAL ANALGESIC  - camphor (natural) and menthol salve 
Carma Laboratories, Inc.

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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CARMEX original lip balm EXTERNAL ANALGESIC


Active Ingredients

Camphor 1.7%
Menthol 0.7%

Purpose

External Analgesic

Uses:

For temporary relief of the symptoms of dry lips

Warnings

For external use only. When using this product, keep out of eyes. Rinse with water to remove. Stop use and consult a doctor if: condition worsens or rash occurs.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • apply to lips not more than 3 to  4 times daily
  • children under 2 years of age: ask a doctor

Inactive Ingredients

petrolatum, lanolin, cetyl esters, theobroma cacao (cocoa) seed butter, mineral oil, beeswax, flavor, salicylic acid, phenol

CARMEX original lip balm EXTERNAL ANALGESIC 10g (10210-0008-0)

CARMEXExternalAnalgesic1
CARMEX ORIGINAL LIP BALM EXTERNAL ANALGESIC  
camphor (natural), menthol salve
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10210-0008
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (NATURAL) (CAMPHOR (NATURAL)) CAMPHOR (NATURAL)1.7 g  in 100 g
MENTHOL (MENTHOL) MENTHOL0.7 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM 
LANOLIN 
CETYL ESTERS WAX 
COCOA BUTTER 
MINERAL OIL 
YELLOW WAX 
SALICYLIC ACID 
PHENOL 
Packaging
#Item CodePackage Description
1NDC:10210-0008-010 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34810/02/2013
Labeler - Carma Laboratories, Inc. (078358080)
Registrant - Carma Laboratories, Inc. (078358080)
Establishment
NameAddressID/FEIBusiness Operations
Carma Laboratories, Inc.078358080manufacture(10210-0008)

Revised: 10/2013
Document Id: c1755128-8785-444b-989f-a4c4e5211bd3
Set id: 51b73fed-486a-42e3-968d-bbfa767b1d1e
Version: 4
Effective Time: 20131009
 
Carma Laboratories, Inc.