CARMEX ORIGINAL LIP BALM EXTERNAL ANALGESIC - camphor (natural), 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

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, paraffin, beeswax, flavor, salicylic acid, phenol

CARMEX original lip balm EXTERNAL ANALGESIC 7.5g (10210-0011-0)| CARMEX original lip balm EXTERNAL ANALGESIC 7.5g/Jar in Blister Pack (10210-0011-1)

CARMEXExternalAnalgesic2

CARMEXExternalAnalgesic3

JarBlisterCard

CARMEX ORIGINAL LIP BALM EXTERNAL ANALGESIC  
camphor (natural), menthol salve
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10210-0011
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)1.7 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.7 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM (UNII: 4T6H12BN9U)  
LANOLIN (UNII: 7EV65EAW6H)  
CETYL ESTERS WAX (UNII: D072FFP9GU)  
COCOA BUTTER (UNII: 512OYT1CRR)  
PARAFFIN (UNII: I9O0E3H2ZE)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
SALICYLIC ACID (UNII: O414PZ4LPZ)  
PHENOL (UNII: 339NCG44TV)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10210-0011-07.5 g in 1 JAR; Type 0: Not a Combination Product10/02/201308/31/2017
2NDC:10210-0011-11 in 1 BLISTER PACK10/02/201308/31/2017
27.5 g in 1 JAR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34810/02/201308/31/2017
Labeler - Carma Laboratories, Inc. (006090153)
Registrant - Carma Laboratories, Inc. (006090153)
Establishment
NameAddressID/FEIBusiness Operations
Carma Laboratories, Inc.006090153manufacture(10210-0011)

Revised: 11/2016
Document Id: 41fcfe99-460c-1524-e054-00144ff8d46c
Set id: 0f5b2c4c-55f2-4140-b706-f260e2c96cbc
Version: 4
Effective Time: 20161123
 
Carma Laboratories, Inc.