Dr. Smith's Diaper Rash Ointment

Dr. Smith's Diaper Rash Ointment
SPL v1
SPL
SPL Set ID 9f5882f7-d942-5b70-e053-2995a90aefcb
Route
TOPICAL
Published
Effective Date 2018-11-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (100 mg)
Inactive Ingredients
Yellow Wax Lanolin Mineral Oil Olive Oil Paraffin Petrolatum Water Thymol Iodide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2018-01-19

Description

Active Ingredient Zinc Oxide 10%

Storage and Handling

Store between 15 0 and 30 0 C (59 0 and 86 0 F)


Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

Uses

helps treat and prevent diaper rash

protects chafed skin due to diaper rash and helps seal out wetness

Dosage and Administration

Directions

change wet and soiled diapers promptly

cleanse the diaper area

allow to dry

apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.

Storage and Handling

Store between 15 0 and 30 0 C (59 0 and 86 0 F)

Description

Active Ingredient Zinc Oxide 10%

Section 50565-1

Keep this and all drugs out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

See a doctor if condition lasts more than 7 days.

Section 50567-7

When using this product, avoid contact with the eyes.

Section 51727-6

Inactive Ingredients

Beeswax, lanolin, mineral oil, olive oil, paraffin wax, petrolatum, purified water, thymol iodide

Section 51945-4

Section 55105-1

Purpose

Skin Protectant

Section 55106-9

Active Ingredient

Zinc Oxide 10%

Section 60561-8

To report a serious adverse event of obtain product information, call (502)709-7544.


Structured Label Content

Indications and Usage (34067-9)

Uses

helps treat and prevent diaper rash

protects chafed skin due to diaper rash and helps seal out wetness

Dosage and Administration (34068-7)

Directions

change wet and soiled diapers promptly

cleanse the diaper area

allow to dry

apply ointment 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)

Warnings

For external use only

Section 50565-1 (50565-1)

Keep this and all drugs out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

See a doctor if condition lasts more than 7 days.

Section 50567-7 (50567-7)

When using this product, avoid contact with the eyes.

Section 51727-6 (51727-6)

Inactive Ingredients

Beeswax, lanolin, mineral oil, olive oil, paraffin wax, petrolatum, purified water, thymol iodide

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

Skin Protectant

Section 55106-9 (55106-9)

Active Ingredient

Zinc Oxide 10%

Section 60561-8 (60561-8)

To report a serious adverse event of obtain product information, call (502)709-7544.

Storage and Handling

Store between 15 0 and 30 0 C (59 0 and 86 0 F)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)