MEDERMA FOR KIDS- allantoin gel

Mederma for Kids by

Drug Labeling and Warnings

Mederma for Kids 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

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)

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

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

Inactive Ingredients
Ingredient Name	Strength
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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0259-1101-20	1 in 1 CARTON	05/01/2014
1		20 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 FINAL	part347	05/01/2014

Labeler - Merz Pharmaceuticals, LLC (126209282)