DIMETHICONE- body shield cream

Dimethicone by

Drug Labeling and Warnings

Dimethicone by is a Otc medication manufactured, distributed, or labeled by McKesson, Central Solutions. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredient
Dimethicone 5%

PURPOSE

Purpose
Skin Protectant

INDICATIONS & USAGE

Uses
for the treatment and/or prevention of diaper rash
temporarily protects and helps relieve chapped or cracked skin

WARNINGS

Warnings
For external use only.
When using this product

• do not get into eyes

Do not use on

• deep or puncture wounds
• animal bites
• serious burns

STOP USE

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

Keep out of reach of children.
If swallowed, get medical help or contact a poison control center right away.

DOSAGE & ADMINISTRATION

Directions

• Cleanse skin with Thera Moisturizing Body Cleanser or Thera Foaming Body Cleanser
• Apply cream liberally until entire area is covered
• Apply as needed

OTHER SAFETY INFORMATION

Store at 40-95ºF (4-35ºC)

INACTIVE INGREDIENT

Inactive Ingredients:
Purified Water, Glyceryl Stearate, PEG 100 Stearate, Stearic Acid, Aleurites Moluccana Seed Oil,
Cetyl Alcohol, Glycerin, Butylene Glycol, Carthamus Tinctorius (Safflower) Seed Oil,
Dimethicone Crosspolymer, Calcium Pantothenate (Vitamin B5), Maltodextrin, Niacinamide (Vitamin B3),
Pyridoxine HCL (Vitamin B6), Silica, Sodium Ascorbyl Phosphate (Vitamin C), Sodium Starch Octenylsuccinate,
Tocopheryl Acetate (Vitamin E), Disodium EDTA, Sodium Hyaluronate, Aloe Barbadensis Leaf Extract,
Zingiber Officinale (Ginger) Root Extract, Carthamus Tinctorius (Safflower) Oleosomes, Fragrance,
Phenoxyethanol, Caprylyl Glycol, Chlorphenesin, Bisabolol, Lysine, Histidine, Arginine, Aspartic Acid,
Threonine, Serine, Glutamic Acid, Proline, Glycine, Alanine, Valine, Methionine, Isoleucine, Leucine,
Tyrosine, Phenylalanine, Cysteine, Triethanolamine

QUESTIONS

Questions?
Call 1-800-777-4908

PRINCIPAL DISPLAY PANEL

NDC: 68599-0213-4
McKesson
Thera
DIMETHICONE BODY SHIELD
Provides mild skin protection against irritation from chapped or cracked skin.
Single Patient Use
NET CONTENTS 4 fl oz (118 mL)
MFR # 53-DS4

INGREDIENTS AND APPEARANCE

DIMETHICONE 
body shield cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68599-0213
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	50 ug  in 1 mg

Inactive Ingredients
Ingredient Name	Strength
VALINE (UNII: HG18B9YRS7)
PHENYLALANINE (UNII: 47E5O17Y3R)
CYSTEINE (UNII: K848JZ4886)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
KUKUI NUT OIL (UNII: TP11QR7B8R)
SAFFLOWER OIL (UNII: 65UEH262IS)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
CALCIUM PANTOTHENATE (UNII: 568ET80C3D)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CETYL ALCOHOL (UNII: 936JST6JCN)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
OCTENYLSUCCINIC ACID (UNII: 12UZE4X73L)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
PROLINE (UNII: 9DLQ4CIU6V)
GLYCINE (UNII: TE7660XO1C)
ARGININE (UNII: 94ZLA3W45F)
ASPARTIC ACID (UNII: 30KYC7MIAI)
ALANINE (UNII: OF5P57N2ZX)
LEUCINE (UNII: GMW67QNF9C)
TYROSINE (UNII: 42HK56048U)
METHIONINE (UNII: AE28F7PNPL)
TROLAMINE (UNII: 9O3K93S3TK)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
GINGER (UNII: C5529G5JPQ)
LYSINE (UNII: K3Z4F929H6)
THREONINE (UNII: 2ZD004190S)
GLUTAMIC ACID (UNII: 3KX376GY7L)
ISOLEUCINE (UNII: 04Y7590D77)
PEG-100 STEARATE (UNII: YD01N1999R)
STEARIC ACID (UNII: 4ELV7Z65AP)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
NIACINAMIDE (UNII: 25X51I8RD4)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
CHLORPHENESIN (UNII: I670DAL4SZ)
HISTIDINE (UNII: 4QD397987E)
SERINE (UNII: 452VLY9402)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
LEVOMENOL (UNII: 24WE03BX2T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68599-0213-4	118 mg in 1 BOTTLE; Type 0: Not a Combination Product	08/12/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	08/12/2019

Labeler - McKesson (023904428)