Indications and uses
Helps treat and prevent diaper rash protects chafed skin due to diaper rash and helps seal out wetness
Balmex Diaper Rash
- Manufacturer
- MOBERG PHARMA NORTH AMERICA LLC
- Effective date
- 2019-05-30
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 8
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 00:19:16
Label at a glance#
ProductBalmex Diaper Rash
Active ingredientZinc Oxide
Label structure8 sections
Dosage and administration
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
Contacts and useful links#
Websitewww.balmex.com
www.balmex.com
www.balmex.comLabel contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
OTC - PURPOSE SECTION
| 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.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
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
INACTIVE INGREDIENT SECTION
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.
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
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Zinc Oxide | ACTIVE INGREDIENT | SOI2LOH54Z | 1 | |
| Zinc Oxide | ACTIVE MOIETY | SOI2LOH54Z | 1 | |
| Benzoic Acid | INACTIVE INGREDIENT | 8SKN0B0MIM | 1 | |
| Dimethicone | INACTIVE INGREDIENT | 92RU3N3Y1O | 1 | |
| Magnesium Aspartate | INACTIVE INGREDIENT | R17X820ROL | 1 | |
| Methylparaben | INACTIVE INGREDIENT | A2I8C7HI9T | 1 | |
| Microcrystalline Wax | INACTIVE INGREDIENT | XOF597Q3KY | 1 | |
| Mineral Oil | INACTIVE INGREDIENT | T5L8T28FGP | 1 | |
| Oenothera Biennis | INACTIVE INGREDIENT | 76UI55V071 | 1 | |
| Olea Europaea Leaf | INACTIVE INGREDIENT | MJ95C3OH47 | 1 | |
| Panthenol | INACTIVE INGREDIENT | WV9CM0O67Z | 1 | |
| Potassium Aspartate | INACTIVE INGREDIENT | OC4598NZEQ | 1 | |
| Potassium Hydroxide | INACTIVE INGREDIENT | WZH3C48M4T | 1 | |
| Propylene Glycol | INACTIVE INGREDIENT | 6DC9Q167V3 | 1 | |
| Propylparaben | INACTIVE INGREDIENT | Z8IX2SC1OH | 1 | |
| Sarcosine | INACTIVE INGREDIENT | Z711V88R5F | 1 | |
| Sorbitan Sesquioleate | INACTIVE INGREDIENT | 0W8RRI5W5A | 1 | |
| Soybean Oil | INACTIVE INGREDIENT | 241ATL177A | 1 | |
| Tocopherol | INACTIVE INGREDIENT | R0ZB2556P8 | 1 | |
| Water | INACTIVE INGREDIENT | 059QF0KO0R | 1 | |
| Yellow Wax | INACTIVE INGREDIENT | 2ZA36H0S2V | 1 |
Products#
Every source-derived product name is available through these pages.
- Balmex Diaper Rash
- Zinc Oxide
- Yellow Wax
- Benzoic Acid
- Dimethicone 100
- Soybean Oil
- Magnesium Aspartate Anhydrous
- Methylparaben
- Microcrystalline Wax
- Mineral Oil
- Oenothera Biennis
- Olea Europaea Leaf
- Dexpanthenol
- Potassium Aspartate
- Potassium Hydroxide
- Propylene Glycol
- Propylparaben
- Sarcosine
- Sorbitan Sesquioleate
- Tocopherol
- Water
- Sodium Cocoyl Glycinate
- White Wax
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 16864-908 | 16864-908-01, 16864-908-02, 16864-908-03, 16864-908-04 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SHAMPOO, SUSPENSION / TOPICAL | 2 %w/w | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SPRAY / NASAL | 5 mg | ||
| Tocopherol | TOCOPHEROL | R0ZB2556P8 | CREAM / TOPICAL | NA | ||
| Methylparaben | METHYLPARABEN | A2I8C7HI9T | GEL / VAGINAL | 8 mg | ||
| Mineral Oil | MINERAL OIL | T5L8T28FGP | GEL / TOPICAL | 2.5 %w/w | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | GEL / OPHTHALMIC | 0.44 %w/w | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION, SOLUTION / INTRAVENOUS | 4000 mg | ||
| Benzoic Acid | BENZOIC ACID | 8SKN0B0MIM | SYRUP / ORAL | 20 mg | ||
| Propylparaben | PROPYLPARABEN | Z8IX2SC1OH | LOTION / TOPICAL | 140 mg | ||
| Methylparaben | METHYLPARABEN | A2I8C7HI9T | INJECTION / PERIDURAL | 1 mg | ||
| Methylparaben | METHYLPARABEN | A2I8C7HI9T | INJECTION / INTRADERMAL | 1 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION, CONCENTRATE / INTRAVENOUS | 50.33 %w/v | ||
| Propylparaben | PROPYLPARABEN | Z8IX2SC1OH | ELIXIR / ORAL | 200 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SWAB / TOPICAL | 34.6 %w/w | ||
| Benzoic Acid | BENZOIC ACID | 8SKN0B0MIM | SUPPOSITORY / VAGINAL | 2 mg | ||
| Propylparaben | PROPYLPARABEN | Z8IX2SC1OH | CREAM, AUGMENTED / TOPICAL | 2 mg | ||
| Methylparaben | METHYLPARABEN | A2I8C7HI9T | CONCENTRATE / ORAL | 12 mg | ||
| Microcrystalline Wax | MICROCRYSTALLINE WAX | XOF597Q3KY | GEL / TOPICAL | NA | ||
| Propylparaben | PROPYLPARABEN | Z8IX2SC1OH | DROPS / NASAL | 14 mg | ||
| Methylparaben | METHYLPARABEN | A2I8C7HI9T | POWDER, FOR SUSPENSION / ORAL | 75 mg | ||
| Benzoic Acid | BENZOIC ACID | 8SKN0B0MIM | INJECTION / INTRAVENOUS | 5 %w/v | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION / ORAL | 27120 mg | ||
| Propylparaben | PROPYLPARABEN | Z8IX2SC1OH | SOLUTION / INTRAVENOUS | 0.02 %w/v | ||
| Methylparaben | METHYLPARABEN | A2I8C7HI9T | AEROSOL, FOAM / TOPICAL | 0.16 %w/w | ||
| Methylparaben | METHYLPARABEN | A2I8C7HI9T | TABLET, CHEWABLE / ORAL | 1.28 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | AEROSOL / TOPICAL | 19.2 %w/w | ||
| Mineral Oil | MINERAL OIL | T5L8T28FGP | SUPPOSITORY / VAGINAL | 30 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / RESPIRATORY (INHALATION) | 25 %w/w | ||
| Mineral Oil | MINERAL OIL | T5L8T28FGP | FILM, EXTENDED RELEASE / TRANSDERMAL | 34 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | CAPSULE / ORAL | 1072 mg | ||
| Methylparaben | METHYLPARABEN | A2I8C7HI9T | SUSPENSION / ORAL | 388 mg | ||
| Potassium Hydroxide | POTASSIUM HYDROXIDE | WZH3C48M4T | INJECTION / INTRAVENOUS | ADJ PH | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | GEL / TOPICAL | 4522 mg | ||
| Benzoic Acid | BENZOIC ACID | 8SKN0B0MIM | GEL / RECTAL | 11 mg | ||
| Methylparaben | METHYLPARABEN | A2I8C7HI9T | INJECTION / INTRAMUSCULAR | 95 mg | ||
| Methylparaben | METHYLPARABEN | A2I8C7HI9T | CAPSULE / ORAL | 7 mg | ||
| Mineral Oil | MINERAL OIL | T5L8T28FGP | CREAM / VAGINAL | 402 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | EMULSION / OPHTHALMIC | 1.5 %w/v | ||
| Potassium Hydroxide | POTASSIUM HYDROXIDE | WZH3C48M4T | SOLUTION / INTRAVASCULAR | NA | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | AEROSOL, METERED / RECTAL | NA | ||
| Soybean Oil | SOYBEAN OIL | 241ATL177A | AEROSOL, FOAM / TOPICAL | 50 %w/w | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | DROPS / ORAL | 200 mg/1ml | ||
| Methylparaben | METHYLPARABEN | A2I8C7HI9T | SOLUTION / OPHTHALMIC | 0.05 %w/w | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | AEROSOL, FOAM / TOPICAL | 1800 mg | ||
| Benzoic Acid | BENZOIC ACID | 8SKN0B0MIM | AEROSOL, FOAM / VAGINAL | 0.1 %w/w | ||
| Propylparaben | PROPYLPARABEN | Z8IX2SC1OH | SOLUTION / ORAL | 100 mg | ||
| Propylparaben | PROPYLPARABEN | Z8IX2SC1OH | SOLUTION / OPHTHALMIC | 0.02 %w/w | ||
| Potassium Hydroxide | POTASSIUM HYDROXIDE | WZH3C48M4T | CAPSULE, LIQUID FILLED / ORAL | 154 mg | ||
| Methylparaben | METHYLPARABEN | A2I8C7HI9T | CREAM / VAGINAL | 22 mg | ||
| Methylparaben | METHYLPARABEN | A2I8C7HI9T | EMULSION / TOPICAL | 0.2 %w/w | ||
| Benzoic Acid | BENZOIC ACID | 8SKN0B0MIM | SOLUTION / TOPICAL | 0.1 %w/w | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SPRAY, METERED / NASAL | 240 mg | ||
| Propylparaben | PROPYLPARABEN | Z8IX2SC1OH | SHAMPOO / TOPICAL | 0.03 %w/w | ||
| Yellow Wax | YELLOW WAX | 2ZA36H0S2V | OINTMENT / TOPICAL | 20 %w/w | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET, DELAYED RELEASE / ORAL | 36 mg | ||
| Methylparaben | METHYLPARABEN | A2I8C7HI9T | SUSPENSION/ DROPS / OPHTHALMIC | 0.05 %w/w | ||
| Soybean Oil | SOYBEAN OIL | 241ATL177A | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 10 %w/v | ||
| Methylparaben | METHYLPARABEN | A2I8C7HI9T | JELLY / TOPICAL | 420 mg | ||
| Mineral Oil | MINERAL OIL | T5L8T28FGP | TABLET, DELAYED RELEASE / ORAL | 5.67 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SHAMPOO / TOPICAL | 8 %w/w |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 9d0692d8-d3a0-4d9e-8621-ad17c80df6d6 | b877ec82-e5bb-cd18-a295-bbd4fc29fd17 | 2019-05-30 | Warnings | 9d0692d8-d3a0-4d9e-8621-ad17c80df6d6 b877ec82-e5bb-cd18-a295-bbd4fc29fd17 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.