MEDLINE- dimethicone cream

Medline by

Drug Labeling and Warnings

Medline by is a Otc medication manufactured, distributed, or labeled by Medline Industries, LP. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Dimethicone 1.5% w/v

Purpose

Skin protectant

Uses

• helps prevent and temporarily protects and helps relieve chapped or cracked skin
• helps prevent and protect from the drying effects of wind and cold weather

Warnings

For external use only

Do not use

• deep or puncture wounds
• animal bites
• serious burns

When using this product

• do not get into eyes

Stope 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.

In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

Directions

• apply one ounce to full body per application, twice daily
• apply especially right after bath or shower for best effect

Other information

• protect from freezing
• avoid excessive heat
• not made with Natural Rubber Latex

Inactive ingredients

acetyl cysteine, aloe barbadensis leaf juice, arginine, ascorbic acid, ascorbyl palmitate, canola oil, cetyl alcohol, cholecalciferol, citric acid, dimethyl sulfone, ethylhexylglycerin, glycerin, glyceryl stearate SE, glycine, hydrated silica, niacinamide, olea europaea (olive) fruit oil, olea europaea leaf extract, olea europaea leaf powder, oleuropein, PEG-8, PEG-100 stearate, phenoxyethanol, proline, propanediol, pyridoxine HCL, retinyl palmitate, stearic acid, stearyl alcohol, taurine, tetrasodium glutamate diacetate, tocopherol, water, zea mays (corn) oil

Manufacturing Information

Manufactured for:

Medline Industries, LP

Three Lakes Drive, Northfield, IL 60093 USA

Made in USA with domestic and foreign materials

www.medline.com

1-800-MEDLINE (633-5463)

REF: MSC0924402UNS

V1 RG23WAR

Package Label

INGREDIENTS AND APPEARANCE

MEDLINE 
dimethicone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53329-155
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	15 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
OLIVE OIL (UNII: 6UYK2W1W1E)
NIACINAMIDE (UNII: 25X51I8RD4)
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)
WATER (UNII: 059QF0KO0R)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
CORN OIL (UNII: 8470G57WFM)
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)
GLYCERIN (UNII: PDC6A3C0OX)
STEARIC ACID (UNII: 4ELV7Z65AP)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
OLEUROPEIN (UNII: 2O4553545L)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
CANOLA OIL (UNII: 331KBJ17RK)
CETYL ALCOHOL (UNII: 936JST6JCN)
CHOLECALCIFEROL (UNII: 1C6V77QF41)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PEG-100 STEARATE (UNII: YD01N1999R)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
PROPANEDIOL (UNII: 5965N8W85T)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ACETYLCYSTEINE (UNII: WYQ7N0BPYC)
TAURINE (UNII: 1EQV5MLY3D)
PROLINE (UNII: 9DLQ4CIU6V)
ARGININE (UNII: 94ZLA3W45F)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCINE (UNII: TE7660XO1C)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53329-155-13	59 mL in 1 TUBE; Type 0: Not a Combination Product	08/01/2023
2	NDC: 53329-155-04	118 mL in 1 TUBE; Type 0: Not a Combination Product	09/01/2023
3	NDC: 53329-155-23	946 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	09/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	08/01/2023

Labeler - Medline Industries, LP (025460908)

Registrant - Medline Industries, LP (025460908)