MENTHOLATUM MEDICATED LIP BALM ORIGINAL- dimethicone, octinoxate, octisalate ointment

Mentholatum Medicated Lip Balm by

Drug Labeling and Warnings

Mentholatum Medicated Lip Balm by is a Otc medication manufactured, distributed, or labeled by The Mentholatum Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Dimethicone 1%

Octinoxate 7.5%

Octisalate 5%

Purpose

Dimethicone - Skin protectant

Octinoxate - Sunscreen

Octisalate - Sunscreen

Uses

• helps prevent sunburn
• temporarily protects chapped or cracked lips

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 prevent sunburn, not skin cancer or early skin aging.

For external use only

Do not use

on damaged or broken skin

When using this product

Keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

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

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
• use a water resistant sunscreen if swimming or sweating
• reapply at least every 2 hours
• children under 6 months: ask a doctor

Other information

• protect this product from excessive heat and direct sun

Inactive ingredients

fragrance, lanolin, menthol, mineral oil, ozokerite, petrolatum

Questions?

Toll free 1-877-636-2677

MON-FRI 9 AM to 5 PM (EST)

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INGREDIENTS AND APPEARANCE

MENTHOLATUM MEDICATED LIP BALM  ORIGINAL
dimethicone, octinoxate, octisalate ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10742-8865
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	10 mg  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
LANOLIN (UNII: 7EV65EAW6H)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
MINERAL OIL (UNII: T5L8T28FGP)
CERESIN (UNII: Q1LS2UJO3A)
PETROLATUM (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10742-8865-1	1 in 1 BLISTER PACK	08/01/2016
1		4.2 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 10742-8865-3	3 in 1 BLISTER PACK	10/01/2018
2		4.2 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 not final	part352	08/01/2016

Labeler - The Mentholatum Company (002105757)