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NDC 00259-1101-20 Mederma for Kids 10 mg/g Details

Mederma for Kids 10 mg/g

Mederma for Kids is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by Merz Pharmaceuticals, LLC. The primary component is ALLANTOIN.

Product Information

NDC	00259-1101
Product ID	0259-1101_a996c79d-4c17-42b1-9288-1d0aed0353a3
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 for Kids
Proprietary Name Suffix	n/a
Non-Proprietary Name	Allantoin
Product Type	HUMAN OTC DRUG
Dosage Form	GEL
Route	TOPICAL
Active Ingredient Strength	10
Active Ingredient Units	mg/g
Substance Name	ALLANTOIN
Labeler Name	Merz Pharmaceuticals, LLC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part347
Listing Certified Through	n/a

Package

Package Images

NDC 00259-1101-20 (00259110120)

Pricing Information	N/A
NDC Package Code	0259-1101-20
Billing NDC	00259110120
Package	1 TUBE in 1 CARTON (0259-1101-20) / 20 g in 1 TUBE
Marketing Start Date	2014-05-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL d9bdf1c9-c9c5-4827-a273-a954ace4b1a5 Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Allantoin 1%

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

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, PEG-4, Xanthan Gum, Alcohol, Allium Cepa (Onion) Bulb Extract, Fragrance, Methylparaben, Sorbic Acid, D&C Violet No. 2, FD&C Red No. 4.

Questions or Comments?

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

PRINCIPAL DISPLAY PANEL - 20 g Tube Carton

SKIN CARE FOR SCARS™

MEDERMA®

for Kids™

FROM THE LEADER IN SCAR MANAGEMENT

NET WT. 0.70 OZ. (20g)

Principal Display Panel - 20 g Tube Carton

INGREDIENTS AND APPEARANCE

MEDERMA FOR KIDS

allantoin gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0259-1101
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Allantoin (UNII: 344S277G0Z) (Allantoin - UNII:344S277G0Z)	Allantoin	10 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
water (UNII: 059QF0KO0R)
POLYETHYLENE GLYCOL 200 (UNII: R95B8J264J)
ONION (UNII: 492225Q21H)
ALCOHOL (UNII: 3K9958V90M)
XANTHAN GUM (UNII: TTV12P4NEE)
METHYLPARABEN (UNII: A2I8C7HI9T)
SORBIC ACID (UNII: X045WJ989B)
EXT. D&C VIOLET NO. 2 (UNII: G5UX3K0728)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)

Product Characteristics
Color	PURPLE	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0259-1101-20	1 in 1 CARTON	05/01/2014	08/31/2023
1		20 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part347	05/01/2014	08/31/2023

Labeler - Merz Pharmaceuticals, LLC (126209282)

Revised: 2/2022

Document Id: a996c79d-4c17-42b1-9288-1d0aed0353a3

Set id: d9bdf1c9-c9c5-4827-a273-a954ace4b1a5

Version: 6

Effective Time: 20220222