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.

Active Ingredient

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

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

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.

Active Ingredient (55106-9)

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

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)

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