Carmex Moisturising Lip Balm

Carmex Moisturising Lip Balm by

Drug Labeling and Warnings

Carmex Moisturising Lip Balm by is a Otc medication manufactured, distributed, or labeled by Carma Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

CARMEX MOISTURISING LIP BALM- camphor (synthetic), petrolatum 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 Moisturising Lip Balm

Drug Facts

Active Ingredients

Camphor 1.70%

White Petrolatum 46.16%

Purpose

External Analgesic

Lip Protectant

Uses

  • helps provide relief of symptoms of cold sores and dry lips

Warnings

For external use only

When using this product:

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if:

  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days

Do not use on:

  • deep puncture wounds
  • serious burns
  • animal bites

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

Other Information

  • this is a personal care item, and should be used by one individual only
  • protect this product from excessive heat and direct sun

Inactive Ingredients

petrolatum, lanolin, cera alba, cetyl esters, paraffin, theobroma cacao seed butter, camphor, menthol, salicylic acid, aroma, vanillin

Package Labeling: 10210-0026-1

Outer PackageInner Package

Package Labeling: 10210-0026-2

Outer Package2Inner Package2

CARMEX MOISTURISING LIP BALM 
camphor (synthetic), petrolatum salve
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 10210-0026
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)17 mg  in 1 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM461.6 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
LANOLIN (UNII: 7EV65EAW6H)  
WHITE WAX (UNII: 7G1J5DA97F)  
CETYL ESTERS WAX (UNII: D072FFP9GU)  
COCOA BUTTER (UNII: 512OYT1CRR)  
MENTHOL (UNII: L7T10EIP3A)  
SALICYLIC ACID (UNII: O414PZ4LPZ)  
VANILLIN (UNII: CHI530446X)  
PARAFFIN (UNII: I9O0E3H2ZE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 10210-0026-11 in 1 BLISTER PACK06/01/202008/10/2020
17.5 g in 1 JAR; Type 0: Not a Combination Product
2NDC: 10210-0026-21 in 1 BLISTER PACK06/01/202008/20/2020
210 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34806/01/202008/20/2020
Labeler - Carma Laboratories, Inc. (006090153)
Establishment
NameAddressID/FEIBusiness Operations
Carma Laboratories, Inc.006090153manufacture(10210-0026)

Revised: 12/2020
Document Id: b59827c4-2e2b-5a0d-e053-2a95a90aa891
Set id: 9dff2418-031e-1308-e053-2995a90accb4
Version: 2
Effective Time: 20201203