BALMEX ADULT CARE RASH- zinc oxide cream

Balmex Adult Care Rash by

Drug Labeling and Warnings

Balmex Adult Care 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 relieve and prevent rashes and irritation due to wetness from incontinence
• protects chafed skin due to irritation and helps seal out wetness

Warnings

For external use only

When using this product

• avoid contact with eyes

Stop use and ask a doctor if

• condition worsens
• symptoms persist 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

• gently cleanse affected skin
• pat dry with a clean, soft cloth or allow to air dry
• apply generously to affected area as needed, especially after incontinence episodes
• using a dry tissue to remove excess product from skin is most effective

STORAGE AND HANDLING

INACTIVE INGREDIENT

Inactive ingredients mineral oil, water, beeswax, microcrystalline wax, synthetic beeswax, fragrance, sorbitan sesquioleate, oenothera biennis (evening primrose) seed extract, olea europaea (olive) leaf extract, dimethicone, tocopherol, methylparaben, glycine soja (soybean) oil, propylparaben, panthenol, sarcosine, benzoic acid, potassium aspartate, potassium hydroxide, magnesium aspartate, sodium cocoyl amino acids (309-021) 

QUESTIONS

For more information please visit 
www.BalmexAdult.com

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL

ActivGuard™

NEUTRALIZES IRRITANTS

Balmex®
ADULT CARE™
RASH CREAM

ZINC OXIDE 11.3%

Soothes & Protects Skin

From Irritation, Chafing & Rash

Dermatologist Tested
Works in One Use*
Odor-Free

NET WT 3 OZ (85 g)

Balmex® Adult Care™ Rash Cream is designed specifically to soothe and protect skin from the irritation, chafing, and rash caused by bladder leakage and proven to work in just one use.*

Powered by three proven ingredients:
Exclusive ActivGuard™ technology neutralizes irritants
Vitamin E soothes and improves the healthy look of your skin
Zinc oxide helps seal out wetness and prevent future rashes

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

82-3903-02

*Proven to work to reduce redness with first use.

For more information please visit www.BalmexAdult.com

Soothes & Protects Skin
From Irritation, Chang & Rash

Balmex®
ADULT CARE™
RASH CREAM

ActivGuard™

NEUTRALIZES IRRITANTS

ZINC OXIDE 11.3%

NET WT 12 OZ (340 g)

Balmex® Adult Care™ Rash Cream

When bladder leakage irritates your skin, it can seem impossible to get relief. Persistent moisture, painful friction, tough to reach and treat. Could there be a worse place to get a rash?

Now there's Balmex Adult Care Rash Cream—designed specifically to soothe and protect skin from the irritation, chafing, and rash caused by bladder leakage and proven to work in just one use.*

Powered by three proven ingredients:
Exclusive ActivGuard™ technology neutralizes irritants
Vitamin E soothes and improves the healthy look of your skin
Zinc oxide helps seal out wetness and prevent future rashes

For more information please visit: www.BalmexAdult.com

*Proven to work to reduce redness with first use.

Distributed by
Moberg Pharma North America LLC
Cedar Knolls, NJ 07927
© 2016 All Rights Reserved.
Made in Canada.
81-3909-02

INGREDIENTS AND APPEARANCE

BALMEX ADULT CARE RASH  
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 16864-902
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
Mineral Oil (UNII: T5L8T28FGP)
Water (UNII: 059QF0KO0R)
Yellow Wax (UNII: 2ZA36H0S2V)
Microcrystalline Wax (UNII: XOF597Q3KY)
Sorbitan Sesquioleate (UNII: 0W8RRI5W5A)
Oenothera Biennis (UNII: 76UI55V071)
Olea Europaea Leaf (UNII: MJ95C3OH47)
Dimethicone 100 (UNII: RO266O364U)
Tocopherol (UNII: R0ZB2556P8)
Methylparaben (UNII: A2I8C7HI9T)
Soybean Oil (UNII: 241ATL177A)
Propylparaben (UNII: Z8IX2SC1OH)
Dexpanthenol (UNII: 1O6C93RI7Z)
Sarcosine (UNII: Z711V88R5F)
Benzoic Acid (UNII: 8SKN0B0MIM)
Potassium Aspartate (UNII: OC4598NZEQ)
Potassium Hydroxide (UNII: WZH3C48M4T)
Magnesium Aspartate Anhydrous (UNII: 082H981FMA)
Sodium Cocoyl Glycinate (UNII: XLU9KH03XM)
Propylene Glycol (UNII: 6DC9Q167V3)
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: 16864-902-01	1 in 1 CARTON	04/27/2015	02/28/2021
1		85 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 16864-902-02	1 in 1 CARTON	04/27/2015	03/31/2020
2		340 g in 1 JAR; 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	04/27/2015	02/28/2021

Labeler - MOBERG PHARMA NORTH AMERICA LLC (192527062)