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:

Medicated

Package Labeling:10210-0022-7

Outer Package Inner Package

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	1.7 g in 100 g
WHITE PETROLATUM (UNII: B6E5W8RQJ4) (WHITE PETROLATUM - UNII:B6E5W8RQJ4)	WHITE PETROLATUM	45.3 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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
7	NDC:10210-0022-7	12 in 1 BOX	01/01/2023
7		10 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M017	09/26/2016

Labeler - Carma Laboratories, Inc. (006090153)

Carmex Classic Lip Balm Medicated