CARMEX CLASSIC LIP BALM MEDICATED (camphor- synthetic, white 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, beeswax, cetyl esters, paraffin, theobroma cacao seed butter, menthol, salicylic acid, phenol, vanillin, flavor

Package Labeling:10210-0039-1

Package Labeling:10210-0039-2

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10210-0039
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	17 mg  in 1 g
WHITE PETROLATUM (UNII: B6E5W8RQJ4) (WHITE PETROLATUM - UNII:B6E5W8RQJ4)	WHITE PETROLATUM	453 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
LANOLIN (UNII: 7EV65EAW6H)
YELLOW WAX (UNII: 2ZA36H0S2V)
CETYL ESTERS WAX (UNII: D072FFP9GU)
PARAFFIN (UNII: I9O0E3H2ZE)
MENTHOL (UNII: L7T10EIP3A)
SALICYLIC ACID (UNII: O414PZ4LPZ)
PHENOL (UNII: 339NCG44TV)
VANILLIN (UNII: CHI530446X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10210-0039-2	3 in 1 BLISTER PACK	09/26/2016
1		7.5 g in 1 JAR; Type 0: Not a Combination Product
2	NDC: 10210-0039-1	7.5 g in 1 JAR; 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 Drug	M017	09/26/2016

Labeler - Carma Laboratories, Inc. (006090153)