Diaper Rash Cream. Drug Facts

SPL v2

SPL

SPL Set ID 958c5e9c-daa6-4aed-a9aa-f72041d0d67c

Route

TOPICAL

Published

Effective Date 2010-03-12

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Zinc Oxide (7.8 mL) Avena Sativa Flowering Top (.6 mL) Medium-chain Triglycerides (18.21 mL) Lanolin (2.4 mL)

Inactive Ingredients

Petrolatum Wax, Yellow Sorbitan Monostearate Glyceryl Monostearate Stearyl Alcohol Phenoxyethanol Butylated Hydroxytoluene

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH FINAL Active Since 2010-04-01

Description

Quickly eliminates redness and Rash thanks to its unique combination of calendula, chamomile and oat extracts.

Medication Information

Warnings and Precautions

Warnings: Do not apply to an open wound. Stop use and ask doctor if irritation or rash persists.

Description

Quickly eliminates redness and Rash thanks to its unique combination of calendula, chamomile and oat extracts.

Section 34093-5

Made in Mexico by Corpsain SA de CV.

www.corpsain.com [email protected]

Phone +(52) 81 83 46 5800

Imported and Distributed by Montdani International LCC. [email protected]

Phone (830) 626 0468

Section 51727-6

Other Ingredients: Petrolatum, Yellow Wax, Sorbitan Monostereate, Glycerlyl Monostearate, Stearyl Alcohol, Butylated Hydroxytoluene.

Section 51945-4

Section 55106-9

Zinc oxide, Avena Sativa Flowering Top, Medium-Chain Triglycerides, Lanolin, Matricaria Recutita, Allantoin, Calendula Officinalis Flower.

Drug Facts

Quickly eliminates redness and Rash thanks to its unique combination of calendula, chamomile and oat extracts.

Directions for Use

Directions for use: Apply a thick layer to the affected area on each diaper change, after cleansing and drying skin completely.

Structured Label Content

Warnings and Precautions (34071-1)

Warnings: Do not apply to an open wound. Stop use and ask doctor if irritation or rash persists.

Section 34093-5 (34093-5)

Made in Mexico by Corpsain SA de CV.

www.corpsain.com [email protected]

Phone +(52) 81 83 46 5800

Imported and Distributed by Montdani International LCC. [email protected]

Phone (830) 626 0468

Section 51727-6 (51727-6)

Other Ingredients: Petrolatum, Yellow Wax, Sorbitan Monostereate, Glycerlyl Monostearate, Stearyl Alcohol, Butylated Hydroxytoluene.

Section 51945-4 (51945-4)

Section 55106-9 (55106-9)

Zinc oxide, Avena Sativa Flowering Top, Medium-Chain Triglycerides, Lanolin, Matricaria Recutita, Allantoin, Calendula Officinalis Flower.

Drug Facts

Quickly eliminates redness and Rash thanks to its unique combination of calendula, chamomile and oat extracts.

Directions for Use (Directions for use)

Directions for use: Apply a thick layer to the affected area on each diaper change, after cleansing and drying skin completely.

Advanced Ingredient Data

[{"name": "ZINC OXIDE", "unii": "SOI2LOH54Z", "classCode": "ACTIB", "strengthNumerator": "7.8", "strengthDenominator": "60", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "AVENA SATIVA FLOWERING TOP", "unii": "MA9CQJ3F7F", "classCode": "ACTIB", "strengthNumerator": ".6", "strengthDenominator": "60", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "MEDIUM-CHAIN TRIGLYCERIDES", "unii": "C9H2L21V7U", "classCode": "ACTIB", "strengthNumerator": "18.21", "strengthDenominator": "60", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "LANOLIN", "unii": "7EV65EAW6H", "classCode": "ACTIB", "strengthNumerator": "2.4", "strengthDenominator": "60", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "PETROLATUM", "unii": "4T6H12BN9U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WAX, YELLOW", "unii": "2ZA36H0S2V", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITAN MONOSTEARATE", "unii": "NVZ4I0H58X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERYL MONOSTEARATE", "unii": "230OU9XXE4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STEARYL ALCOHOL", "unii": "2KR89I4H1Y", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PHENOXYETHANOL", "unii": "HIE492ZZ3T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BUTYLATED HYDROXYTOLUENE", "unii": "1P9D0Z171K", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34071-1": "Warnings: Do not apply to an open wound. Stop use and ask doctor if irritation or rash persists.", "34093-5": "Made in Mexico by Corpsain SA de CV. www.corpsain.com sales@corpsain.com Phone +(52) 81 83 46 5800 Imported and Distributed by Montdani International LCC. info@Montdani.com Phone (830) 626 0468", "51727-6": "Other Ingredients: Petrolatum, Yellow Wax, Sorbitan Monostereate, Glycerlyl Monostearate, Stearyl Alcohol, Butylated Hydroxytoluene.", "55106-9": "Zinc oxide, Avena Sativa Flowering Top, Medium-Chain Triglycerides, Lanolin, Matricaria Recutita, Allantoin, Calendula Officinalis Flower.", "Drug Facts": "Quickly eliminates redness and Rash thanks to its unique combination of calendula, chamomile and oat extracts.", "Directions for use": "Directions for use: Apply a thick layer to the affected area on each diaper change, after cleansing and drying skin completely."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:01.683247 · Updated: 2026-03-14T22:52:20.145878