CARMEX CLASSIC LIP BALM MEDICATED FREE WINTERGREEN STICK (octinoxate, oxybenzone, camphor- synthetic, white petrolatum kit

Carmex Classic Lip Balm Medicated Free Wintergreen Stick by

Drug Labeling and Warnings

Carmex Classic Lip Balm Medicated Free Wintergreen Stick 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

Octinoxate 7.50%

Oxybenzone 4.00%

Uses

helps protect against sunburn
higher SPF gives more sunburn protection

Warnings

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

When using this product:

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if:

rash occurs

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

apply liberally 15 minutes before sun exposure
reapply: after 80 minutes of swimming or sweating immediately after towel drying
at least every 2 hours
children under 2 years of age: ask a doctor

Inactive Ingredients

petrolatum, lanolin, euphorbia cerifera (candelilla) wax, isopropyl palmitate, ozokerite, beeswax, cetyl esters, paraffin, theobroma cacao (cocoa) seed butter, flavor, limnanthes alba (meadowfoam) seed oil, stevia rebaudiana extract

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

When using this product:

keep out of eyes.

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

Inactive Ingredients

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

Package Labeling:10210-0047-1

Package labeling:10210-0038-0

Package Labeling:10210-0033-1

INGREDIENTS AND APPEARANCE

CARMEX CLASSIC LIP BALM MEDICATED FREE WINTERGREEN STICK 
octinoxate, oxybenzone, camphor (synthetic), white petrolatum kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10210-0047

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10210-0047-1	1 in 1 KIT	06/20/2018

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 CYLINDER	4.25 g
Part 2	1 TUBE	10 g

Part 1 of 2

CARMEX DAILY CARE MOISTURIZING LIP BALM WINTERGREEN SPF 15 
octinoxate, oxybenzone salve

Product Information
Item Code (Source)	NDC: 10210-0033
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	40 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
PETROLATUM (UNII: 4T6H12BN9U)
LANOLIN (UNII: 7EV65EAW6H)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
CERESIN (UNII: Q1LS2UJO3A)
YELLOW WAX (UNII: 2ZA36H0S2V)
CETYL ESTERS WAX (UNII: D072FFP9GU)
PARAFFIN (UNII: I9O0E3H2ZE)
MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10210-0033-1	4.25 g in 1 CYLINDER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	06/20/2018

Part 2 of 2

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

Product Information
Item Code (Source)	NDC: 10210-0038
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)
MINERAL OIL (UNII: T5L8T28FGP)
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: 10210-0038-0	10 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	06/20/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	06/20/2018

Labeler - Carma Laboratories, Inc. (006090153)