CARMEX CLASSIC LIP BALM MEDICATED (camphor- synthetic, petrolatum salve

Carmex Classic Lip Balm Medicated by

Drug Labeling and Warnings

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

Drug Details [pdf]

Drug Facts

Active Ingredients

Camphor 1.70%

White Petrolatum 45.30%

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

lanolin, cetyl esters, theobroma cacao seed butter, paraffin, beeswax, menthol, salicylic acid, phenol, vanillin, flavor

Package Labeling:

INGREDIENTS AND APPEARANCE

CARMEX CLASSIC LIP BALM MEDICATED 
camphor (synthetic), petrolatum salve

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10210-0022
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	1.77 g  in 100 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	45.3 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
LANOLIN (UNII: 7EV65EAW6H)
CETYL ESTERS WAX (UNII: D072FFP9GU)
COCOA BUTTER (UNII: 512OYT1CRR)
PARAFFIN (UNII: I9O0E3H2ZE)
YELLOW WAX (UNII: 2ZA36H0S2V)
MENTHOL (UNII: L7T10EIP3A)
SALICYLIC ACID (UNII: O414PZ4LPZ)
PHENOL (UNII: 339NCG44TV)
VANILLA (UNII: Q74T35078H)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10210-0022-1	1 in 1 BLISTER PACK	09/26/2016
1		7.5 g in 1 JAR; Type 0: Not a Combination Product
2	NDC: 10210-0022-2	3 in 1 PACKAGE	09/26/2016
2		7.5 g in 1 JAR; Type 0: Not a Combination Product
3	NDC: 10210-0022-3	7.5 g in 1 JAR; Type 0: Not a Combination Product	09/26/2016
4	NDC: 10210-0022-4	1 in 1 BLISTER PACK	09/26/2016
4		10 g in 1 TUBE; Type 0: Not a Combination Product
5	NDC: 10210-0022-5	3 in 1 PACKAGE	09/26/2016
5		10 g in 1 TUBE; Type 0: Not a Combination Product
6	NDC: 10210-0022-6	10 g in 1 TUBE; Type 0: Not a Combination Product	09/26/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	09/26/2016

Labeler - Carma Laboratories, Inc. (006090153)