MEDERMA STRETCH MARKS THERAPY- dimethicone cream

Mederma Stretch Marks Therapy by

Drug Labeling and Warnings

Mederma Stretch Marks Therapy by is a Otc medication manufactured, distributed, or labeled by HRA Pharma America, Inc., Merz Pharma GmbH & Co KGaA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Dimethicone 2%

Purpose

Skin Protectant

Uses

• Temporarily protects and helps relieve chapped or cracked skin

Warnings

• For external use only

When using this product

• Do not get into eyes

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

Do not use on

• Deep or punctured wounds
• Animal bites
• Serious burns

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Apply as needed

Other Information

• Store at room temperature

Inactive Ingredients

• Water, Cetearyl Alcohol, C12-15 Alkyl Benzoate, Pentylene Glycol, Dicaprylyl Carbonate, Glycerin, Arachidyl Alcohol, Alcohol, Cyclopentasiloxane, Behenyl Alcohol, Cyclohexasiloxane, Ethoxydiglycol, Arachidyl Glucoside, Allium Cepa (Onion) Bulb Extract, Cetearyl Glucoside, Tocopheryl Acetate, Sodium Hyaluronate, Fragrance, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Hydroxyethylcellulose, Disodium EDTA, Hydrolyzed Collagen, Asiaticoside, Asiatic Acid, Madecassic Acid, Polysorbate 60, Sorbitan Isostearate, Hydrolyzed Soy Protein, Sodium Hydroxide, Tocopherol, Iron Oxides, Sodium Benzoate

Questions or Comments?

• For more information call 1-833-426-6733 or visit www.mederma.com

PRINCIPAL DISPLAY PANEL

MEDERMA®

Stretch Marks
Therapy

Clinically shown to treat stretch marks by:

● Hydrating the skin

● Reducing discoloration

● Improving texture

No 1 
Doctor & Pharmacist recommended scar brand

Skin Protectant
1x CREAM TUBE
NET WT. 5.29 Oz (150g)

Unique Triple-Action Formula penetrates into the skin

INGREDIENTS AND APPEARANCE

MEDERMA STRETCH MARKS THERAPY 
dimethicone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73302-204
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
dimethicone (UNII: 92RU3N3Y1O) (dimethicone - UNII:92RU3N3Y1O)	dimethicone	2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
Cetostearyl Alcohol (UNII: 2DMT128M1S)
Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)
Pentylene Glycol (UNII: 50C1307PZG)
Dicaprylyl Carbonate (UNII: 609A3V1SUA)
Glycerin (UNII: PDC6A3C0OX)
Arachidyl Alcohol (UNII: 1QR1QRA9BU)
Alcohol (UNII: 3K9958V90M)
Cyclomethicone 5 (UNII: 0THT5PCI0R)
Docosanol (UNII: 9G1OE216XY)
Cyclomethicone 6 (UNII: XHK3U310BA)
Diethylene Glycol Monoethyl Ether (UNII: A1A1I8X02B)
Arachidyl Glucoside (UNII: 6JVW35JOOJ)
Onion (UNII: 492225Q21H)
Cetearyl Glucoside (UNII: 09FUA47KNA)
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)
Hyaluronate Sodium (UNII: YSE9PPT4TH)
Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer (100000 Mpa.S At 1.5%) (UNII: 86FQE96TZ4)
Hydroxyethyl Cellulose (2000 Mpa.S At 1%) (UNII: S38J6RZN16)
Edetate Disodium Anhydrous (UNII: 8NLQ36F6MM)
Bovine Type I Collagen (UNII: FHJ3ATL51C)
Asiaticoside (UNII: PKO39VY215)
Asiatic Acid (UNII: 9PA5A687X5)
Madecassic Acid (UNII: M7O1N24J82)
Polysorbate 60 (UNII: CAL22UVI4M)
Sorbitan Isostearate (UNII: 01S2G2C1E4)
Soy Protein (UNII: R44IWB3RN5)
Sodium Hydroxide (UNII: 55X04QC32I)
Tocopherol (UNII: R0ZB2556P8)
Ferric Oxide Red (UNII: 1K09F3G675)
Sodium Benzoate (UNII: OJ245FE5EU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73302-204-15	1 in 1 BOX	10/01/2020
1		150 g in 1 TUBE; 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	10/01/2020

Labeler - HRA PHARMA AMERICA, INC. (081160441)