DIMETHICONE- body cleanser liquid

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 1.75%

PURPOSE

Purpose
Skin Protectant

INDICATIONS & USAGE

Uses

• temporarily protects and helps relieve chapped or cracked skin
• cleanses, moisturizes, and helps protect skin
• it can be used on face, body and perineal area

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

• Apply cleanser to damp cloth or to skin/ perineal area and then gently wipe clean
• No rinsing necessary
• Apply as needed
• Apply a protectant cream as necessary

OTHER SAFETY INFORMATION

Store at 40-95ºF (4-35ºC)

INACTIVE INGREDIENT

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

QUESTIONS

Questions?
Call 1-800-777-4908

PRINCIPAL DISPLAY PANEL

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

INGREDIENTS AND APPEARANCE

DIMETHICONE 
body cleanser liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68599-0212
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	17.5 ug  in 1 mg

Inactive Ingredients
Ingredient Name	Strength
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)
METHIONINE (UNII: AE28F7PNPL)
LEUCINE (UNII: GMW67QNF9C)
TYROSINE (UNII: 42HK56048U)
PHENYLALANINE (UNII: 47E5O17Y3R)
CYSTEINE (UNII: K848JZ4886)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
ALANINE (UNII: OF5P57N2ZX)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
SERINE (UNII: 452VLY9402)
VALINE (UNII: HG18B9YRS7)
THREONINE (UNII: 2ZD004190S)
LEVOMENOL (UNII: 24WE03BX2T)
LYSINE (UNII: K3Z4F929H6)
HISTIDINE (UNII: 4QD397987E)
ARGININE (UNII: 94ZLA3W45F)
GLUTAMIC ACID (UNII: 3KX376GY7L)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
NIACINAMIDE (UNII: 25X51I8RD4)
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)
OCTENYLSUCCINIC ACID (UNII: 12UZE4X73L)
GINGER (UNII: C5529G5JPQ)
KUKUI NUT OIL (UNII: TP11QR7B8R)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PEG-100 STEARATE (UNII: YD01N1999R)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
ISOLEUCINE (UNII: 04Y7590D77)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TROLAMINE (UNII: 9O3K93S3TK)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309)
CALCIUM PANTOTHENATE (UNII: 568ET80C3D)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68599-0212-8	237 mg in 1 BOTTLE; Type 0: Not a Combination Product	08/13/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	08/13/2019

Labeler - McKesson (023904428)