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, fragrance, 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: MSC0924402

V1 RL22WAR

Package Label

Label V1 RL22WAR

MEDLINE
dimethicone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:53329-154
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:53329-154-13	59 mL in 1 TUBE; Type 0: Not a Combination Product	09/01/2023
2	NDC:53329-154-04	118 mL in 1 TUBE; Type 0: Not a Combination Product	11/01/2023
3	NDC:53329-154-23	946 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	11/01/2023
4	NDC:53329-154-84	1000 mL in 1 BAG; Type 0: Not a Combination Product	11/01/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M016	09/01/2023

Labeler - Medline Industries, LP (025460908)

Registrant - Medline Industries, LP (025460908)

154 Remedy Specialized Skin Cream (scented)