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 Merz Pharmaceuticals, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

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 puncture wounds
• animal bites
• serious burns

If pregnant or breastfeeding, ask a health professional before use

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, Allium Cepae (Onion) Bulb Extract, Cetearyl Alcohol, C12-15 Alkyl Benzoate, Dicaprylyl Carbonate, Glycerin, Pentylene Glycol, Cyclomethicone, Arachidyl Alcohol, Alcohol, Behenyl Alcohol, Arachidyl Glucoside, Ethoxydiglycol, Cetearyl Glucoside, Tocopheryl Acetate, Fragrance, Sodium Hyaluronate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Hydroxyethylcellulose, Disodium EDTA, Centella Asiatica Leaf Extract, Hydrolyzed Collagen, Hydrolyzed Soy Protein, Sodium Hydroxide, Iron Oxides.

Questions or comments?

For more information call 1-888-925-8989 or visit www.mederma.com

PRINCIPAL DISPLAY PANEL - 150 g Tube Box

MEDERMA®

stretch
marks
therapy

Improve appearance
Reduce discoloration
Smooth texture
Enhance softness

Hydrates
to
HELP
PREVENT
stretch
marks

DERMATOLOGIST
RECOMMENDED

Clinically shown to
produce noticeable
improvement in
just 4 weeks

PARABEN FREE
intensive cream
and skin protectant

NET WT. 5.29 OZ. (150g)

INGREDIENTS AND APPEARANCE

MEDERMA STRETCH MARKS THERAPY 
dimethicone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0259-2102
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
dimethicone (UNII: 92RU3N3Y1O) (dimethicone - UNII:92RU3N3Y1O)	dimethicone	20 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
Edetate Disodium (UNII: 7FLD91C86K)
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) (UNII: S38J6RZN16)
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
Docosanol (UNII: 9G1OE216XY)
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
Cetearyl Glucoside (UNII: 09FUA47KNA)
Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)
Dicaprylyl Carbonate (UNII: 609A3V1SUA)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
FERRIC OXIDE RED (UNII: 1K09F3G675)
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)
CYCLOMETHICONE (UNII: NMQ347994Z)
ONION (UNII: 492225Q21H)
Glycerin (UNII: PDC6A3C0OX)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
CENTELLA ASIATICA LEAF (UNII: 6810070TYD)
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
BOVINE TYPE I COLLAGEN (UNII: FHJ3ATL51C)
SOY PROTEIN (UNII: R44IWB3RN5)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0259-2102-15	1 in 1 BOX	12/01/2013
1		150 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 0259-2102-05	0.5 g in 1 PACKET; Type 0: Not a Combination Product	12/01/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part347	12/01/2013

Labeler - Merz Pharmaceuticals, LLC (126209282)