BALMEX DIAPER RASH- zinc oxide cream

Balmex Diaper Rash by

Drug Labeling and Warnings

Balmex Diaper Rash by is a Otc medication manufactured, distributed, or labeled by MOBERG PHARMA NORTH AMERICA LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

ACTIVE INGREDIENT

• Active ingredients: Purpose
• Zinc Oxide 11.3%: Skin protectant

Uses

• Helps treat and prevent diaper rash
• protects chafed skin due to diaper rash and helps seal out wetness

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.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

• change wet or soiled diapers promptly, cleanse the diaper area, and allow to dry
• apply cream liberally as often as necessary, with each diaper change, especially at bedtime or any time when exposure to wet diapers may be prolonged

Other information

• do not use if quality seal is broken
• see bottom of carton and or top of tube for lot number and expiration date

STORAGE AND HANDLING

INACTIVE INGREDIENT

Inactive ingredients Beeswax, benzoic acid, dimethicone, fragrance, glycine soja (soybean) oil, magnesium aspartate, methylparaben, microcrystalline wax, mineral oil, oenothera biennis (evening primrose) seed extract, olea europea (olive) leaf extract, panthenol, potassium aspartate, potassium hydroxide, propylparaben, sarcosine, sodium cocoyl amino acids, sorbitan sesquioleate, synthetic beeswax, tocopherol, water (245-230)

Questions?

1-800-345-0032

Distributed by
Moberg Pharma North America LLC
Cedar Knolls, NJ 07927
© 2015 All Rights Reserved. Made in Canada.

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

NEW LOOK-SAME PRODUCT

Balmex®
COMPLETE PROTECTION™

Zinc Oxide
Diaper Rash Cream
Crema Para Dermatitis del Pañal

Advanced Formula

Prevents
✓ Protects against all 3 leading causes of diaper rash

Heals
✓ Reduces rash in just 1 diaper change

Pediatrician Recommended

Trusted by Moms for over 50 years

NET WT 16 OZ (453 g)

Questions? / Preguntas?
1-800-345-0032
Distributed by
Moberg Pharma North America LLC
Cedar Knolls, NJ 07927
© 2015 All Rights Reserved. Made in Canada.
81-3910-04

www.balmex.com

NEW LOOK-SAME PRODUCT

Balmex®
COMPLETE PROTECTION™

Zinc Oxide
Diaper Rash Cream
Crema Para Dermatitis del Pañal

Prevents & Heals

✓ Protects against all 3 leading causes of diaper rash

✓ Reduces rash in just 1 diaper change

Pediatrician Recommended

Advanced Formula

NET WT 2 OZ (56 g)

EXTRA PROTECTION
for your baby's comfort

Balmex Complete Protection™ protects against all 3 leading causes of diaper rash to help keep your baby comfortable and rash-free.

IT PROTECTS AGAINST:
✓ Diaper Wetness
✓ Skin Chafing
PLUS
✓ Digestive Enzymes found in dirty diapers that irritate skin

Balmex's Advanced Formula is designed to help stop the rash before it starts by providing extra protection against skin irritation. If a rash develops, Balmex will work quickly to relieve discomfort and help heal the rash. In fact, a clinical study shows that Balmex Complete Protection™ reduces diaper rash in just 1 diaper change.

Balmex contains the #1 Doctor recommended ingredient for the treatment of diaper rash plus soothing vitamins B5 and E. It goes on smoothly allowing for gentle application and removal to keep baby's delicate skin comfortable.

Recommended by Pediatricians & Trusted by Moms for over 50 years.

Questions? / Preguntas?
1-800-345-0032

©2016 Distributed by Moberg Pharma North America LLC, Cedar Knolls, NJ 07927
All Rights Reserved. Made in Canada.

82-3901-03

www.balmex.com

NEW LOOK- SAME PRODUCT

Balmex®
COMPLETE PROTECTION

Zinc Oxide
DIAPER RASH CREAM
Crema Para Dermatitis del Pañal

Prevents & Heals

✓Protects against all 3 leading causes of diaper rash

✓Reduces rash in just 1 diaper change

Advanced Formula

NET WT 0.18oz

Distributed by Moberg Pharma North America LLC
Cedar Knolls, NJ 07927, © 2016
All Rights Reserved. Made in Canada.

81-3912-03

www.balmex.com

SAMPLE - NOT FOR RESALE

INGREDIENTS AND APPEARANCE

BALMEX DIAPER RASH  
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 16864-908
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	.113 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Yellow Wax (UNII: 2ZA36H0S2V)
Benzoic Acid (UNII: 8SKN0B0MIM)
Dimethicone 100 (UNII: RO266O364U)
Soybean Oil (UNII: 241ATL177A)
Magnesium Aspartate Anhydrous (UNII: 082H981FMA)
Methylparaben (UNII: A2I8C7HI9T)
Microcrystalline Wax (UNII: XOF597Q3KY)
Mineral Oil (UNII: T5L8T28FGP)
Oenothera Biennis (UNII: 76UI55V071)
Olea Europaea Leaf (UNII: MJ95C3OH47)
Dexpanthenol (UNII: 1O6C93RI7Z)
Potassium Aspartate (UNII: OC4598NZEQ)
Potassium Hydroxide (UNII: WZH3C48M4T)
Propylene Glycol (UNII: 6DC9Q167V3)
Propylparaben (UNII: Z8IX2SC1OH)
Sarcosine (UNII: Z711V88R5F)
Sorbitan Sesquioleate (UNII: 0W8RRI5W5A)
Tocopherol (UNII: R0ZB2556P8)
Water (UNII: 059QF0KO0R)
Sodium Cocoyl Glycinate (UNII: XLU9KH03XM)
White Wax (UNII: 7G1J5DA97F)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 16864-908-01	1 in 1 CARTON	04/27/2015	05/31/2021
1		113 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 16864-908-02	453 g in 1 JAR; Type 0: Not a Combination Product	04/27/2015	06/30/2021
3	NDC: 16864-908-03	1 in 1 CARTON	04/27/2015	02/28/2021
3		56 g in 1 TUBE; Type 0: Not a Combination Product
4	NDC: 16864-908-04	5.1 g in 1 PACKAGE; Type 0: Not a Combination Product	02/25/2016	01/31/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	04/27/2015	06/30/2021

Labeler - MOBERG PHARMA NORTH AMERICA LLC (192527062)