DIMETHICONE- body shield cream 
McKesson

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Body Shield Dimethicone

Drug Facts

Active Ingredient
Dimethicone 5%

Purpose
Skin Protectant

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

Warnings
For external use only.
When using this product

Do not use on

Stop use and ask a doctor if

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

Directions


Store at 40-95ºF (4-35ºC)

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?
Call 1-800-777-4908

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

53-DS4

DIMETHICONE 
body shield cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68599-0213
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE50 ug  in 1 mg
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68599-0213-4118 mg in 1 BOTTLE; Type 0: Not a Combination Product08/12/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34708/12/2019
Labeler - McKesson (023904428)
Establishment
NameAddressID/FEIBusiness Operations
Central Solutions007118524manufacture(68599-0213)

Revised: 1/2021
Document Id: b8e111ef-8ba1-5293-e053-2995a90ad928
Set id: 8febb45d-a200-702c-e053-2995a90a3e62
Version: 3
Effective Time: 20210114
 
McKesson