Balmex® Diaper Rash

Balmex® Diaper Rash
SPL v1
SPL
SPL Set ID f202dd0e-7c61-4ea1-a5f6-e90898366ba3
Route
TOPICAL
Published
Effective Date 2018-11-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (0.113 g)
Inactive Ingredients
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

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH FINAL Active Since 2015-04-27
Description

Drug Facts

Medication Information

Description

Drug Facts

Uses
  • Helps treat and prevent diaper rash
  • protects chafed skin due to diaper rash and helps seal out wetness
When
  • do not get into eyes.
Section 42229-5

Drug Facts

Section 50565-1

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

Section 51727-6

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)

Section 55105-1
Active ingredients  Purpose
Zinc Oxide 11.3% Skin protectant
Warnings

For external use only                

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
Questions?

1-833-389-9450



Dist. by: RANDOB LABS LTD. Box 440, Cornwall, NY 12518

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
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.

Principal Display Panel 113 G Tube Carton

NEW LOOK-SAME PRODUCT

Balmex®

COMPLETE

PROTECTION™

Zinc Oxide

DIAPER RASH CREAM

Prevents & Heals

  • ✔
    Protects against

    all 3 leading causes

    of diaper rash
  • ✔
    Reduces rash in

    just 1 diaper change

Pediatrician Recommended

Advanced

Formula

NET WT 4 OZ (113 g)

Structured Label Content

Uses
  • Helps treat and prevent diaper rash
  • protects chafed skin due to diaper rash and helps seal out wetness
When
  • do not get into eyes.
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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

Section 51727-6 (51727-6)

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)

Section 55105-1 (55105-1)
Active ingredients  Purpose
Zinc Oxide 11.3% Skin protectant
Warnings

For external use only                

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
Questions?

1-833-389-9450



Dist. by: RANDOB LABS LTD. Box 440, Cornwall, NY 12518

Other Information (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
Stop Use and Ask A Doctor If (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.

Principal Display Panel 113 G Tube Carton (PRINCIPAL DISPLAY PANEL - 113 g Tube Carton)

NEW LOOK-SAME PRODUCT

Balmex®

COMPLETE

PROTECTION™

Zinc Oxide

DIAPER RASH CREAM

Prevents & Heals

  • ✔
    Protects against

    all 3 leading causes

    of diaper rash
  • ✔
    Reduces rash in

    just 1 diaper change

Pediatrician Recommended

Advanced

Formula

NET WT 4 OZ (113 g)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:40.920025 · Updated: 2026-03-14T22:55:19.604592