DIMETHICONE AND PETROLATUM cream

DIMETHICONE and PETROLATUM by

Drug Labeling and Warnings

DIMETHICONE and PETROLATUM by is a Otc medication manufactured, distributed, or labeled by Greenbrier International, Inc., Lab Douce Cosmetics (Shenzhen) Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Dimethicone 1%

White petrolatum 30%

Purpose

Skin protectant

Uses

• helps relieve, prevent and temporarily protect chafed, chapped or cracked skin

Warnings

For external use only

For adult use only

Do not use on

• ​deep or puncture wounds
• animal bites
• serious burns

When using this product

avoid contact with eyes.

Stop use and ask a doctor if

• condition worsens
• redness, irritation, swelling or pain persists or increases
• symptoms persist for 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 generously to affected area as needed

Other information

• store at 20 oC-25 oC (68 oF to 77 oF)

Inactive Ingredients

water, ammonium polyacrylate, glycerin, glyceryl stearate, cetearyl alcohol, triethanolamine, carbomer, panthenol, tocopheryl acetate, methylisothiazolinone

Distributed By

GREENBRIER INTERNATIONAL, INC. 500 VOLVO PARKWAY, CHESAPEAKE, VA 23320 MADE IN CHINA

PRINCIPAL DISPLAY PANEL

Diabetics' Foot Cream SKIN PROTECTANT NET WT. 4.5 OZ (128 g)

Product Label

INGREDIENTS AND APPEARANCE

DIMETHICONE AND PETROLATUM 
dimethicone and petrolatum cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 33992-8870
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	30 g  in 100 g
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
PANTHENOL (UNII: WV9CM0O67Z)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)
TROLAMINE (UNII: 9O3K93S3TK)
GLYCERIN (UNII: PDC6A3C0OX)
POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
CETYL ALCOHOL (UNII: 936JST6JCN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 33992-8870-1	128 g in 1 TUBE; Type 0: Not a Combination Product	08/21/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	08/21/2016

Labeler - Greenbrier International, Inc. (610322518)

Establishment
Name	Address	ID/FEI	Business Operations
Lab Douce Cosmetics (Shenzhen) Co., Ltd.		529303186	manufacture(33992-8870)