Balmex Diaper Rash Cream

Balmex Diaper Rash Cream
SPL v3
SPL
SPL Set ID f7f7a89d-d4e0-9faa-e053-6294a90aaf7b
Route
TOPICAL
Published
Effective Date 2023-03-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (11.3 g)
Inactive Ingredients
Benzoic Acid Dimethicone 350 Soybean Oil Magnesium Aspartate Microcrystalline Wax Mineral Oil Evening Primrose Oil Olea Europaea Leaf Panthenol Balsam Peru Phenoxyethanol Potassium Aspartate Potassium Hydroxide Sarcosine Coco Acid Chlorides Sorbitan Sesquioleate Synthetic Beeswax Tocopherol Water Yellow Wax

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-04-19
Description

Zinc Oxide 11.3%

Medication Information

Warnings and Precautions

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.

Indications and Usage

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

Dosage and Administration

Change wet and 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 anytime when exposure to wet diapers may be prolonged.

Description

Zinc Oxide 11.3%

Section 50565-1

If swallowed, seek medical help or contact a Poison Control Center immediately.

Section 51727-6

Beeswax, benzoic acid, dimethicone, glycine soja (soybean) oil, magnesium aspartate, microcrystalline wax, mineral oil, oenothera biennis (evening primrose) seed extract, olea europae (olive) leaf extract, panthenol, Peruvian balsam, Phenoxyethanol, potassium aspartate, potassium hydroxide, sarcosine, sodium cocoyl amino acids, sorbitan sesquioleate, synthetic beeswax, tocopherol, water.

Section 51945-4

Section 55105-1

Skin Protectant

Section 55106-9

Zinc Oxide 11.3%

Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

Change wet and 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 anytime when exposure to wet diapers may be prolonged.

Warnings and Precautions (34071-1)

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.

Section 50565-1 (50565-1)

If swallowed, seek medical help or contact a Poison Control Center immediately.

Section 51727-6 (51727-6)

Beeswax, benzoic acid, dimethicone, glycine soja (soybean) oil, magnesium aspartate, microcrystalline wax, mineral oil, oenothera biennis (evening primrose) seed extract, olea europae (olive) leaf extract, panthenol, Peruvian balsam, Phenoxyethanol, potassium aspartate, potassium hydroxide, sarcosine, sodium cocoyl amino acids, sorbitan sesquioleate, synthetic beeswax, tocopherol, water.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Skin Protectant

Section 55106-9 (55106-9)

Zinc Oxide 11.3%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:50.586105 · Updated: 2026-03-14T23:05:54.616139