PROCURE DIMETHICONE 5%- dimethicone cream

Procure Dimethicone 5% by

Drug Labeling and Warnings

Procure Dimethicone 5% by is a Otc medication manufactured, distributed, or labeled by Twin Med LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Dimethicone 5%

Purpose

Skin Protectant

Uses

Uses

• temporaily protects and helps relieve chafed, chapped or cracked skin
• helps protect from the drying effects of whine and cold weather
• helps treat and prevent diaper rash
• protects minor skin irritation associated with diaper rash and helps seal out wetness

Warnings

Warnings

For external use only

When using this product

When using this product do not get into eyes.

Stop use and ask a doctor if

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. In case of accidental ingestion contact a physician or Poison Control Center right away.

Directions

Directions

As a skin protectant apply as needed

As a diaper cream

• change wet and soiled diaper promptly, cleanse the diaper area and allow to dry
• apply cream liberally as often as necessary with each diaper change, expecially at bedtime or anytime when exposure to wet diaper may be prolonged

Inactive Ingredients

Water, Glyceryl Monostearate, Stearic Acid, PEG-100 Monostearate, Cetostearyl Alcohol, Glycerin, Propylene Glycol, Niacinamide, Pehenoxyethanol, Aloe Vera Leaf, Zea Mays Oil, Fragrance, Carbomer, Trolamine, Edetate Disodium, Orange Oil Cold Pressed, Canola Oil, Citrus Medica Limonum (Lemon) Peel Oil, Lavender Oil, Olive Oil, .Alpha.-Tocopherol Acetate, Ascorbyl Palmitate, Pyridoxine HCl, Vitamin A Palmitate, Cholecalciferol, Ethylhexylglycerin

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PROCURE DIMETHICONE 5% 
dimethicone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55681-024
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
NIACINAMIDE (UNII: 25X51I8RD4)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
CANOLA OIL (UNII: 331KBJ17RK)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
LEMON OIL, COLD PRESSED (UNII: I9GRO824LL)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
OLIVE OIL (UNII: 6UYK2W1W1E)
ORANGE OIL, COLD PRESSED (UNII: AKN3KSD11B)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TROLAMINE (UNII: 9O3K93S3TK)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
WATER (UNII: 059QF0KO0R)
ZEA MAYS (CORN) OIL (UNII: 8470G57WFM)
PYRIDOXINE HCL (UNII: 68Y4CF58BV)
PEG-100 MONOSTEARATE (UNII: YD01N1999R)
STEARIC ACID (UNII: 4ELV7Z65AP)
CHOLECALCIFEROL (UNII: 1C6V77QF41)
LAVENDER OIL (UNII: ZBP1YXW0H8)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55681-024-04	113 g in 1 TUBE; Type 0: Not a Combination Product	06/28/2025
2	NDC: 55681-024-14	144 in 1 CARTON	06/28/2025
2	NDC: 55681-024-05	5 g in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	06/28/2025

Labeler - Twin Med LLC (009579330)