SOFTLIPS WATERMELON, TROPICAL COCONUT, PEACH PASSION- dimethicone stick

Softlips Watermelon, Tropical Coconut, Peach Passion by

Drug Labeling and Warnings

Softlips Watermelon, Tropical Coconut, Peach Passion 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 2%

Purpose

Dimethicone - Skin protectant

Uses

• helps prevent and temporarily protects chapped or cracked lips
• helps prevent and protect from the drying effects of wind and cold weather

Warnings

For external use only

When using this product

do not get into 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

Keep Out of Reach of Children

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

Directions

apply as needed

Inactive ingredients

ozokerite, petrolatum, ethylhexyl palmitate, squalane, octyldodecanol, myristyl myristate, ricinus communis (castor) seed oil, myristyl lactate, flavor, cetyl alcohol, myristyl laurate, myristyl alcohol, BHT, menthol, tocopheryl acetatate [vitamin E]

Questions?

1-877-636-2677 MON-FRI 9AM to 5PM (EST) softlips.com

Package/Label Principal Display Panel

Package/Label Principal Display Panel

INGREDIENTS AND APPEARANCE

SOFTLIPS WATERMELON, TROPICAL COCONUT, PEACH PASSION 
dimethicone stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10742-7003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	20 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CERESIN (UNII: Q1LS2UJO3A)
PETROLATUM (UNII: 4T6H12BN9U)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
SQUALANE (UNII: GW89575KF9)
OCTYLDODECANOL (UNII: 461N1O614Y)
MYRISTYL MYRISTATE (UNII: 4042ZC00DY)
CASTOR OIL (UNII: D5340Y2I9G)
MYRISTYL LACTATE (UNII: 1D822OC34X)
CETYL ALCOHOL (UNII: 936JST6JCN)
MYRISTYL LAURATE (UNII: 58U0NZN2BT)
MYRISTYL ALCOHOL (UNII: V42034O9PU)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10742-7003-3	3 in 1 BLISTER PACK	10/15/2018
1		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 final	part347	10/15/2018

Labeler - The Mentholatum Company (002105757)