SOFTLIPS PEPPERMINT SWIRL- dimethicone stick

Softlips Peppermint Swirl by

Drug Labeling and Warnings

Softlips Peppermint Swirl by is a Otc medication manufactured, distributed, or labeled by The Mentholatum Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Dimethicone 2%

Purpose

Dimethicone - Skin Protectant

Uses

• temporarily protects and helps relieve chapped or cracked lips
• helps 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, ammonium glycyrrhizate, BHT, menthol, tocopheryl acetate [vitamin E]

Questions?

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

Package Label/Principal Display Panel

Package Label/Principal Display Panel

INGREDIENTS AND APPEARANCE

SOFTLIPS PEPPERMINT SWIRL 
dimethicone stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10742-8518
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
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
CETYL ALCOHOL (UNII: 936JST6JCN)
SQUALANE (UNII: GW89575KF9)
AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)
PETROLATUM (UNII: 4T6H12BN9U)
MYRISTYL LACTATE (UNII: 1D822OC34X)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CERESIN (UNII: Q1LS2UJO3A)
RICINUS COMMUNIS (CASTOR) SEED OIL (UNII: D5340Y2I9G)
MYRISTYL LAURATE (UNII: 58U0NZN2BT)
OCTYLDODECANOL (UNII: 461N1O614Y)
MYRISTYL MYRISTATE (UNII: 4042ZC00DY)
MYRISTYL ALCOHOL (UNII: V42034O9PU)
MENTHOL (UNII: L7T10EIP3A)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10742-8518-2	2 in 1 BLISTER PACK	07/14/2023
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 Drug	M016	07/14/2023

Labeler - The Mentholatum Company (002105757)

Registrant - The Mentholatum Company (002105757)

Establishment
Name	Address	ID/FEI	Business Operations
The Mentholatum Company		002105757	manufacture(10742-8518)