DIMETHICONE- skin protectant 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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Moisturizing body cream

Drug Facts

Active Ingredient:
Dimethicone 1.75%

Purpose
Skin Protectant

Uses
Temporarily protects and helps relieve chapped or cracked skin
beneficial for face, hands, body and legs

Warnings
For external use only.

When using this product, do not get into eyes

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
Apply cream liberally as needed

Store at 40-95ºF (4-35ºC).

Inactive Ingredients:
Purified Water, Aleurites Moluccana Seed Oil, Stearic Acid, Cetyl Alcohol, Glycerin, Glyceryl Stearate,
PEG 100 Stearate, Carthamus Tinctorius (Safflower) Seed Oil, Dimethicone Crosspolymer, Butylene Glycol,
Sodium Hyaluronate, Aloe Barbadensis Leaf Extract, Zingiber Officinale (Ginger) Root Extract,
Carthamus Tinctorius (Safflower) Oleosomes, 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), Bisabolol, Lysine, Histidine,
Arginine, Aspartic Acid, Threonine, Serine, Glutamic Acid, Proline, Glycine, Alanine, Valine,
Methionine, Isoleucine, Leucine, Tyrosine, Phenylalanine, Cysteine, Fragrance, Phenoxyethanol,
Caprylyl Glycol, Chlorphenesin, Disodium EDTA, Triethanolamine

Questions?
Call 1-800-777-4908


NDC 68599-0218-4
McKesson
Thera
MOISTURIZING BODY CREAM
Everyday moisturizer and skin conditioner.
Single Patient Use
NET CONTENTS 4 fl oz (118 mL)
MFR # 53-CRM4
53-CRM4


NDC 68599-0218-8
McKesson
Thera
MOISTURIZING BODY CREAM
Everyday moisturizer and skin conditioner.
Single Patient Use
NET CONTENTS 32 fl oz (946 mL)
MFR # 53-CRM32
53-CRM32


NDC 68599-0218-1
McKesson
Thera
MOISTURIZING BODY CREAM
Refill for McKesson Pump Dispenser MFR # 53-1000.
NET CONTENTS 1000 mL (34 fl. oz.)
MFR # 53-CRM1000
53-CRM1000

DIMETHICONE 
skin protectant cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68599-0218
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE17.5 ug  in 1 mg
Inactive Ingredients
Ingredient NameStrength
KUKUI NUT OIL (UNII: TP11QR7B8R)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
GINGER (UNII: C5529G5JPQ)  
CARTHAMUS TINCTORIUS FLOWER BUD (UNII: B86IS274O0)  
CALCIUM PANTOTHENATE (UNII: 568ET80C3D)  
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)  
ARGININE (UNII: 94ZLA3W45F)  
ASPARTIC ACID (UNII: 30KYC7MIAI)  
PROLINE (UNII: 9DLQ4CIU6V)  
METHIONINE (UNII: AE28F7PNPL)  
SERINE (UNII: 452VLY9402)  
ALANINE (UNII: OF5P57N2ZX)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
CARTHAMUS TINCTORIUS FLOWER OIL (UNII: SDQ136WIM5)  
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
THREONINE (UNII: 2ZD004190S)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
LEVOMENOL (UNII: 24WE03BX2T)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
WATER (UNII: 059QF0KO0R)  
NIACINAMIDE (UNII: 25X51I8RD4)  
OCTENYLSUCCINIC ACID (UNII: 12UZE4X73L)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
VALINE (UNII: HG18B9YRS7)  
ISOLEUCINE (UNII: 04Y7590D77)  
PHENYLALANINE (UNII: 47E5O17Y3R)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
LYSINE (UNII: K3Z4F929H6)  
HISTIDINE (UNII: 4QD397987E)  
GLUTAMIC ACID (UNII: 3KX376GY7L)  
GLYCINE (UNII: TE7660XO1C)  
LEUCINE (UNII: GMW67QNF9C)  
CYSTEINE (UNII: K848JZ4886)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
TYROSINE (UNII: 42HK56048U)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68599-0218-4118 mg in 1 TUBE; Type 0: Not a Combination Product11/04/2019
2NDC:68599-0218-8946 mg in 1 BOTTLE; Type 0: Not a Combination Product11/04/2019
3NDC:68599-0218-11000 mg in 1 BAG; Type 0: Not a Combination Product11/04/201901/01/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34711/04/2019
Labeler - McKesson (023904428)
Establishment
NameAddressID/FEIBusiness Operations
Central Solutions007118524manufacture(68599-0218)

Revised: 9/2021
Document Id: cc6ec5ba-542e-5f7e-e053-2a95a90aec43
Set id: 96886b33-44d4-5a2a-e053-2a95a90a505e
Version: 2
Effective Time: 20210920
 
McKesson