Smart Care ​® Baby DIAPER RASH OINTMENT AND SKIN PROTECTANT

Manufacturer
Ashtel Studios, Inc
Effective date
2021-08-31
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:42:19

Label at a glance#

ProductSmart Care Baby Diaper Rash and Skin Protectant
Active ingredientLANOLIN, PETROLATUM
Label structure10 sections

Indications and uses

• helps treat and prevent diaper rash • protects chafed skin due to diaper rash and helps seal out wetness • temporarily protects minor:    • cuts  • scrapes  • burns • temporarily protects and helps relieve chapped or cracked skin and lips

Dosage and administration

• ​for diaper rash use:   • change wet and soiled diapers promptly, cleanse the diaper area, and 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 •  ​for skin protectant use:  ​apply as needed

Storage and handling

store between 20° to 25°C (68° to 77°F)

Label contents#

Full prescribing information#

​Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Lanolin 15.5%

Petrolatum 53.4%

​Purpose

OTC - PURPOSE SECTION

Diaper rash ointment

Skin protectant

​Uses

INDICATIONS & USAGE SECTION

• helps treat and prevent diaper rash
• protects chafed skin due to diaper rash and helps seal out wetness
• temporarily protects minor:
   • cuts  • scrapes  • burns
• temporarily protects and helps relieve chapped or cracked skin and lips

Warnings

WARNINGS SECTION

​For external use only

Do not use on
• deep or puncture wounds
• animal bites       • serious burns

​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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

​Directions

DOSAGE & ADMINISTRATION SECTION

• ​for diaper rash use:
  • change wet and soiled diapers promptly, cleanse the diaper area, and 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
• ​for skin protectant use: ​apply as needed

​Other information

STORAGE AND HANDLING SECTION

store between 20° to 25°C (68° to 77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

cod liver oil (contains vitamin A & vitamin D), fragrance, light mineral oil, microcrystalline wax, paraffin

​Questions? +1-877-274-8358

OTC - QUESTIONS SECTION

You may report serious side effects to this phone number. Mon - Fri 8:00 AM - 5:00 PM PST

SPL UNCLASSIFIED SECTION

WITH VITAMIN A & D

Helps treat & prevent diaper rash with this soothing ointment and skin protectant, which forms a protective barrier that seals out wetness.

• Dye Free

• Paraben Free

• Phthalates Free

Smart Care®

WWW.SMARTCAREUS.COM

​QUESTIONS OR COMMENTS?
1-877-274-8358 TOLL FREE IN U.S.A
1-909-434-0911 INTERNATIONAL

PATENTS, COPYRIGHTS AND TRADEMARKS GRANTED OR PENDING WORLDWIDE

DISTRIBUTED BY ASHTEL STUDIOS INC.
ONTARIO, CALIFORNIA 91761

DESIGNED IN U.S.A

MADE IN INDIA

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PackagingPackaging

PackagingPackaging

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
664981lanolin 15.5 % / petrolatum 53.4 % Topical OintmentPSN1
664981lanolin 0.155 MG/MG / petrolatum 0.534 MG/MG Topical OintmentSCD1
664981lanolin 15.5 % / petrolatum 53.4 % Topical OintmentSY1
664981lanolin 15.5 GM per 100 GM / petrolatum 53.4 GM per 100 GM Topical OintmentSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70108-073-012024-01-30C16284748780-11030e365-1ef2-111a-e063-dadaa90a10e2Smart Care ​® Baby DIAPER RASH OINTMENT AND SKIN PROTECTANT

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70108-073-01Smart Care Baby Diaper Rash and Skin Protectant1 in 1 BOXOINTMENT11
70108-073-01Smart Care Baby Diaper Rash and Skin Protectant113 g in 1 TUBEOINTMENT1131

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70108-073SMART CARE BABY DIAPER RASH AND SKIN PROTECTANT (LANOLIN, PETROLATUM) OINTMENT [ASHTEL STUDIOS, INC]1Legacy NDC, 2 package rows20210910_56ed51b7-84ce-4078-931a-dbdc413ae783.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70108-07370108-073-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
30d61cda-019a-42ad-88ed-0bd0d131a5c056ed51b7-84ce-4078-931a-dbdc413ae7832021-08-31WarningsExact identifier
spl id: 30d61cda-019a-42ad-88ed-0bd0d131a5c0
spl set id: 56ed51b7-84ce-4078-931a-dbdc413ae783

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.