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 HRA PHARMA AMERICA, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

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 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, PEG-4, Xanthan Gum, Alcohol, Allium Cepa (Onion) Bulb Extract, Fragrance, Methylparaben, Sorbic Acid, Ext. Violet 2, Red 4, Sodium Chloride, Sodium Sulfate

Questions or Comments?

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

PRINCIPAL DISPLAY PANEL

MEDERMA® for Kids™

Clinically shown to visibly reduce the appearance of scars

For Ages 2+

goes on purple & rubs in clear

Unique Triple-Action Formula with kid-friendly scent

No 1 Pediatrician recommended scar brand

Skin Protectant

1 x GEL TUBE

NET WT. 0.7 0z (20g)

INGREDIENTS AND APPEARANCE

MEDERMA FOR KIDS 
allantoin gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73302-202
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Allantoin (UNII: 344S277G0Z) (Allantoin - UNII:344S277G0Z)	Allantoin	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Polyethylene Glycol 200 (UNII: R95B8J264J)
Xanthan Gum (UNII: TTV12P4NEE)
Alcohol (UNII: 3K9958V90M)
Onion (UNII: 492225Q21H)
Methylparaben (UNII: A2I8C7HI9T)
Sorbic Acid (UNII: X045WJ989B)
Ext. D&C Violet No. 2 (UNII: G5UX3K0728)
Fd&C Red No. 4 (UNII: X3W0AM1JLX)
Sodium Chloride (UNII: 451W47IQ8X)
Sodium Sulfate (UNII: 0YPR65R21J)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73302-202-20	1 in 1 CARTON	10/01/2020
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 Drug	M016	10/01/2020

Labeler - HRA PHARMA AMERICA, INC. (081160441)