DIMETHICONE- body cleanser liquid 
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.

----------

Moisturizing Body Cleanser

Drug Facts

Active ingredient
Dimethicone 1.75%

Purpose
Skin Protectant

Uses

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: Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Alanine, Aleurites Moluccana (Kukui) Seed Oil, Aminomethyl Propanol, Arginine, Aspartic Acid, Bisabolol, Butylene Glycol,
Calcium Pantothenate (Vitamin B5), Caprylyl Glycol, Carthamus Tinctorius (Safflower) Oleosomes, Carthamus Tinctorius (Safflower) Seed Oil, Ceteareth-20,
Cetyl Alcohol, Chlorphenesin, Disodium EDTA, Fragrance, ALPHA.-TOCOPHEROL ACETATE Glutamic Acid, Glycerin, Glyceryl Stearate, Glycine, Histidine, Isoleucine, Isopropyl Myristate, Leucine,
Lysine, Maltodextrin, Niacinamide (Vitamin B3), PEG-40 Sorbitan Peroleate, Phenoxyethanol, Phenylalanine, Proline, Purified Water, Pyridoxine HCL (Vitamin B6), Serine,
Silica, Sodium Ascorbyl Phosphate (Vitamin C), Sodium Hyaluronate, Sodium Starch Octenylsuccinate, Stearic Acid, Threonine, Tocopherol Acetate (Vitamin E), Tyrosine,
Valine, Zingiber Officinale (Ginger) Root Extract

Questions?
Call 1-800-777-4908

NDC 68599-0212-8
Thera
MOISTURIZING BODY CLEANSER
A no-rinse topical cleanser
Single Patient Use
NET CONTENTS 8 fl. oz (237 mL)
MFR # 53-MC8

53-MC8

DIMETHICONE 
body cleanser liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68599-0212
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
OCTENYLSUCCINIC ACID (UNII: 12UZE4X73L)  
LEUCINE (UNII: GMW67QNF9C)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
PEG-9 DIGLYCIDYL ETHER/SODIUM HYALURONATE CROSSPOLYMER (UNII: 788QAG3W8A)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
PEG-40 SORBITAN PEROLEATE (UNII: 276639YRZL)  
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)  
WATER (UNII: 059QF0KO0R)  
SAFFLOWER OIL (UNII: 65UEH262IS)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
ASPARTIC ACID (UNII: 30KYC7MIAI)  
PROLINE (UNII: 9DLQ4CIU6V)  
GLYCINE (UNII: TE7660XO1C)  
TYROSINE (UNII: 42HK56048U)  
PHENYLALANINE (UNII: 47E5O17Y3R)  
ALANINE (UNII: OF5P57N2ZX)  
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
SERINE (UNII: 452VLY9402)  
VALINE (UNII: HG18B9YRS7)  
THREONINE (UNII: 2ZD004190S)  
LYSINE (UNII: K3Z4F929H6)  
HISTIDINE (UNII: 4QD397987E)  
ARGININE (UNII: 94ZLA3W45F)  
GLUTAMIC ACID (UNII: 3KX376GY7L)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
NIACINAMIDE (UNII: 25X51I8RD4)  
GINGER (UNII: C5529G5JPQ)  
KUKUI NUT OIL (UNII: TP11QR7B8R)  
GLYCERIN (UNII: PDC6A3C0OX)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
ISOLEUCINE (UNII: 04Y7590D77)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309)  
CALCIUM PANTOTHENATE (UNII: 568ET80C3D)  
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
.BETA.-BISABOLOL (UNII: LP618AV2EA)  
MAGNESIUM DISODIUM EDTA (UNII: NDT563S5VZ)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68599-0212-8237 mg in 1 BOTTLE; Type 0: Not a Combination Product08/13/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34708/13/2019
Labeler - McKesson (023904428)
Establishment
NameAddressID/FEIBusiness Operations
Central Solutions007118524manufacture(68599-0212)

Revised: 9/2021
Document Id: cc994062-9f0e-8be3-e053-2995a90a3f8b
Set id: 8ffe6ec3-8f5f-0c9b-e053-2995a90ac3a8
Version: 4
Effective Time: 20210922
 
McKesson