3M CAVILON DURABLE BARRIER- dimethicone cream

3M Cavilon Durable Barrier by

Drug Labeling and Warnings

3M Cavilon Durable Barrier by is a Otc medication manufactured, distributed, or labeled by 3M Company, Kindeva Drug Delivery Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Dimethicone 1.3%

Purpose

Skin Protectant

Uses

• Temporarily protects and helps relieve chapped or cracked skin

Warnings

• For external use only
• Avoid contact with 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 or puncture wounds
• animal bites
• serious burns

• Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away

Directions

• Apply as needed
• Gently cleanse skin as required
• Apply cream sparingly to cover the entire affected area
• Note: If the feel is oily, too much has been applied

Inactive ingredients

Acrylate Terpolymer, Benzoic Acid, Cocos Nucifera (Coconut) Oil, Dehydroacetic Acid, Diisooctyl Adipate, Glycerin, Isopropyl Palmitate, Magnesium Sulphate, Mineral Oil, Paraffin, Phenoxyethanol, PPG-15 Stearyl Ether, Trimethylsiloxysilicate, Water

Questions?

Call 1-800-228-3957 (Monday to Friday 7AM  6PM CST)

PRINCIPAL DISPLAY PANEL

3M™ NDC: 17518-030-02

Cavilon™ Durable Barrier

Cream

• Protects and moisturizes skin
• Durable, long lasting formula
• Breathable
• Allows tape to adhere
• CHG compatible
• Fragrance free

Not made with Natural Rubber Latex

Active Ingredient made in U.S.A.

©2015, All rights reserved.

3M and Cavilon are trademarks of 3M

REF

3354

Net Weight 1 oz. 28g

Active Ingredient made in U.S.A.

©3M 2015, All rights reserved.

3M and Cavilon are trademarks of 3M

Made in the U.K. by

3M Health Care

2510 Conway Ave

St. Paul, MN 55144

www.3M.com/Cavilon

INGREDIENTS AND APPEARANCE

3M CAVILON DURABLE BARRIER 
dimethicone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 17518-030
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	13000 mg  in 1 L

Inactive Ingredients
Ingredient Name	Strength
BENZOIC ACID (UNII: 8SKN0B0MIM)
COCONUT OIL (UNII: Q9L0O73W7L)
DEHYDROACETIC ACID (UNII: 2KAG279R6R)
DIISOOCTYL ADIPATE (UNII: 2TLQ9O0CWB)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T)
MINERAL OIL (UNII: T5L8T28FGP)
PARAFFIN (UNII: I9O0E3H2ZE)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PPG-15 STEARYL ETHER (UNII: 1II18XLS1L)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 17518-030-03	0.00126 L in 1 TUBE; Type 0: Not a Combination Product	06/01/2016
2	NDC: 17518-030-02	0.000383 L in 1 TUBE; Type 0: Not a Combination Product	06/01/2016
3	NDC: 17518-030-01	0.0000273 L in 1 PACKET; Type 0: Not a Combination Product	06/01/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	06/01/2016

Labeler - 3M Health Care (006173082)

Establishment
Name	Address	ID/FEI	Business Operations
3M Health Care LTD		218829455	manufacture(17518-030) , label(17518-030) , pack(17518-030)

Establishment
Name	Address	ID/FEI	Business Operations
The Dow Chemical Company		171862600	api manufacture(17518-030)