FDA.reportPublic FDA data

TheraCare A&D Ointment

Manufacturer
Veridian Healthcare | Umendra Life Sciences
Effective date
2026-01-29
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:35:19

Label at a glance#

ProductTheraCare A and D
Active ingredientLANOLIN, PETROLATUM
Label structure8 sections

Indications and uses

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

Dosage and administration

for skin protectant use apply as needed 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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION


Lanolin 15.5% .
Petrolatum 53.4% ..

OTC - PURPOSE SECTION

Active ingredientsPurpose
Lanolin 15.5%Skin Protectant
Petrolatum 53.4%Skin Protectant

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only

Do not use on

OTC - DO NOT USE SECTION

  • deep or puncture wounds .
  • animal bites
  • serious burns .

When using this product

OTC - WHEN USING SECTION

  • do not get into eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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. (1-800-222-1222)

Directions

DOSAGE & ADMINISTRATION SECTION

  • for skin protectant use apply as needed
  • 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

Other information

OTHER SAFETY INFORMATION

  • store between 20°C to 25 °C ( 68° to 77°F)
  • do not use if tube seal under cap is broken

Inactive Ingredients

INACTIVE INGREDIENT SECTION


cholecalciferol, light mineral oil, microcrystalline wax, paraffin, vitamin A palmitate

TheraCare A&D Ointment

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
664981lanolin 15.5 % / petrolatum 53.4 % Topical OintmentPSN5
664981lanolin 0.155 MG/MG / petrolatum 0.534 MG/MG Topical OintmentSCD5
664981lanolin 15.5 % / petrolatum 53.4 % Topical OintmentSY5
664981lanolin 15.5 GM per 100 GM / petrolatum 53.4 GM per 100 GM Topical OintmentSY5

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71101-013-01TheraCare A and D1 in 1 CARTONOINTMENT15
71101-013-01TheraCare A and D113 g in 1 TUBEOINTMENT1135

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71101-01371101-013-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
PARAFFINI9O0E3H2ZEIACT
LIGHT MINERAL OILN6K5787QVPIACT
MICROCRYSTALLINE WAXXOF597Q3KYIACT
CHOLECALCIFEROL1C6V77QF41IACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
LANOLIN7EV65EAW6HACTIB
PETROLATUM4T6H12BN9UACTIB

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
TheraCare A and DLANOLIN, PETROLATUMVeridian Healthcare1303aa33-2111-b36c-e063-6294a90af1312026-01-29WarningsExact identifier
ndc (package): 71101-013-01
ndc (product): 71101-013
ndc11 (package): 71101001301
spl id: 498b64c9-bfcd-855b-e063-6394a90a4d9d
spl set id: 1303aa33-2111-b36c-e063-6294a90af131

Reported adverse events (FAERS/openFDA)#

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