summers labs (as pld) - triple paste (11086-021)

SPL v12

SPL

SPL Set ID f9fd9395-48bc-43be-a3d9-ec7fcad339a9

Route

topical

Published

Effective Date 2018-11-19

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

zinc cation (8 g)

Inactive Ingredients

petrolatum starch, corn lanolin stearyl alcohol yellow wax .alpha.-bisabolol, (+)- cholesterol water glycerin oat polysorbate 80

Identifiers & Packaging

Marketing Status

otc monograph drug active Since 2013-10-30

Purpose

SKIN PROTECTANT

Description

ZINC OXIDE 12.8%

Medication Information

Warnings

FOR EXTERNAL USE ONLY

Uses

HELPS TREAT AND PREVENT DIAPER RASH
PROTECTS CHAFED SKIN DUE TO DIAPER RASH AND HELPS PROTECT FROM WETNESS

Purpose

SKIN PROTECTANT

Directions

Change wet and soiled diapers promptly
Cleanse the diaper area and allow skin to dry
Apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or any time exposure to wet diapers may be prolonged

Inactive Ingredients

white petrolatum, corn starch, anhydrous lanolin, stearyl alcohol, beeswax, bisabolol, cholesterol, water, glycerine, oat (avena sativa) kernel extract, polysorbate 80.

Description

ZINC OXIDE 12.8%

Section 50565-1

KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTCT A POISON CONTROL CENTER RIGHT AWAY.

Section 50566-9

Stop and ask a doctor if

condition worsens or does not improve within 7 days

Section 50567-7

When using this product

DO NOT GET INTO EYES

Section 51945-4

Active Ingredient

ZINC OXIDE 12.8%

Structured Label Content

Warnings (WARNINGS)

FOR EXTERNAL USE ONLY

Uses (USES)

HELPS TREAT AND PREVENT DIAPER RASH
PROTECTS CHAFED SKIN DUE TO DIAPER RASH AND HELPS PROTECT FROM WETNESS

Purpose (PURPOSE)

SKIN PROTECTANT

Directions (DIRECTIONS)

Change wet and soiled diapers promptly
Cleanse the diaper area and allow skin to dry
Apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or any time exposure to wet diapers may be prolonged

Inactive Ingredients (INACTIVE INGREDIENTS)

white petrolatum, corn starch, anhydrous lanolin, stearyl alcohol, beeswax, bisabolol, cholesterol, water, glycerine, oat (avena sativa) kernel extract, polysorbate 80.

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTCT A POISON CONTROL CENTER RIGHT AWAY.

Section 50566-9 (50566-9)

Stop and ask a doctor if

condition worsens or does not improve within 7 days

Section 50567-7 (50567-7)

When using this product

DO NOT GET INTO EYES

Section 51945-4 (51945-4)

Active Ingredient (ACTIVE INGREDIENT)

ZINC OXIDE 12.8%

Advanced Ingredient Data

[{"name": "PETROLATUM", "unii": "4T6H12BN9U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LANOLIN", "unii": "7EV65EAW6H", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STEARYL ALCOHOL", "unii": "2KR89I4H1Y", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "YELLOW WAX", "unii": "2ZA36H0S2V", "classCode": "IACT", "strengthNumerator": "8", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": ".ALPHA.-BISABOLOL, (+)-", "unii": "105S6I733Z", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CHOLESTEROL", "unii": "97C5T2UQ7J", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "OAT", "unii": "Z6J799EAJK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYSORBATE 80", "unii": "6OZP39ZG8H", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ZINC CATION", "unii": "13S1S8SF37", "classCode": "ACTIM", "strengthNumerator": "12.8", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"USES": "HELPS TREAT AND PREVENT DIAPER RASH PROTECTS CHAFED SKIN DUE TO DIAPER RASH AND HELPS PROTECT FROM WETNESS", "50565-1": "KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTCT A POISON CONTROL CENTER RIGHT AWAY.", "50566-9": "Stop and ask a doctor if condition worsens or does not improve within 7 days", "50567-7": "When using this product DO NOT GET INTO EYES", "PURPOSE": "SKIN PROTECTANT", "WARNINGS": "FOR EXTERNAL USE ONLY", "DIRECTIONS": "Change wet and soiled diapers promptly Cleanse the diaper area and allow skin to dry Apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or any time exposure to wet diapers may be prolonged", "ACTIVE INGREDIENT": "ZINC OXIDE 12.8%", "INACTIVE INGREDIENTS": "white petrolatum, corn starch, anhydrous lanolin, stearyl alcohol, beeswax, bisabolol, cholesterol, water, glycerine, oat (avena sativa) kernel extract, polysorbate 80."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:01:23.675110 · Updated: 2026-03-14T23:01:24.251815