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NDC 00259-2102-05 Mederma Stretch Marks Therapy 20 mg/g Details

Mederma Stretch Marks Therapy 20 mg/g

Mederma Stretch Marks Therapy is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Merz Pharmaceuticals, LLC. The primary component is DIMETHICONE.

Product Information

NDC	00259-2102
Product ID	0259-2102_e5d09ae0-5fc1-408a-9e8b-018143d25e2b
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Mederma Stretch Marks Therapy
Proprietary Name Suffix	n/a
Non-Proprietary Name	dimethicone
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	20
Active Ingredient Units	mg/g
Substance Name	DIMETHICONE
Labeler Name	Merz Pharmaceuticals, LLC
Pharmaceutical Class	Skin Barrier Activity [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part347
Listing Certified Through	n/a

Package

Package Images

NDC 00259-2102-05 (00259210205)

Pricing Information	N/A
NDC Package Code	0259-2102-05
Billing NDC	00259210205
Package	.5 g in 1 PACKET (0259-2102-05)
Marketing Start Date	2013-12-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 6e84c921-03a7-4ec1-bd9b-4986b5559555 Details

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)

PRINCIPAL DISPLAY PANEL - 150 g Tube Box

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

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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0259-2102-15	1 in 1 BOX	12/01/2013	06/30/2024
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	06/30/2024

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part347	12/01/2013	06/30/2024

Labeler - Merz Pharmaceuticals, LLC (126209282)

Revised: 2/2022

Document Id: e5d09ae0-5fc1-408a-9e8b-018143d25e2b

Set id: 6e84c921-03a7-4ec1-bd9b-4986b5559555

Version: 8

Effective Time: 20220223