DIMETHICONE- skin protectant 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 1.75%

PURPOSE

Purpose
Skin Protectant

INDICATIONS & USAGE

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

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 cream liberally as needed

OTHER SAFETY INFORMATION

Store at 40-95ºF (4-35ºC).

INACTIVE INGREDIENT

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

Questions?
Call 1-800-777-4908

PRINCIPAL DISPLAY PANEL

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

PRINCIPAL DISPLAY PANEL

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

PRINCIPAL DISPLAY PANEL

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

INGREDIENTS AND APPEARANCE

DIMETHICONE 
skin protectant cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68599-0218
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
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68599-0218-4	118 mg in 1 TUBE; Type 0: Not a Combination Product	11/04/2019
2	NDC: 68599-0218-8	946 mg in 1 BOTTLE; Type 0: Not a Combination Product	11/04/2019
3	NDC: 68599-0218-1	1000 mg in 1 BAG; Type 0: Not a Combination Product	11/04/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	11/04/2019

Labeler - McKesson (023904428)

Establishment
Name	Address	ID/FEI	Business Operations
Central Solutions		007118524	manufacture(68599-0218)