FDA.reportPublic FDA data

TheraCare Extra Strength Anti-Itch Cream

Manufacturer
Veridian Healthcare | ANICARE PHARMACEUTICALS PRIVATE LIMITED
Effective date
2024-12-18
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:44:58

Label at a glance#

ProductTheraCare Extra Strength Anti-Itch Cream Itch Stopping
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE
Label structure9 sections

Indications and uses

temporarily relieves pain and itching associated with: insect bites minor burns sunburn minor skin irritations minor cuts scrapes minor skin irritations rashes due to poison ivy, poison oak, oak, and sumac dries the oozing and weeping of poison ivy, poison oak, and poison sumac

Dosage and administration

adults and children 2 years of age and over: apply to affected area not more than 3 to 4 times daily children under 2 years of age: consult a physician

Storage and handling

store at 20°C-25°C (68°C/77°F) do not use if tube seal under cap is broken

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientsPurpose
Diphenhydramine hydrochloride 2%Topical analgesic
Zinc acetate 0.1%Skin protectant

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves pain and itching associated with:
    • insect bites
    • minor burns
    • sunburn
    • minor skin irritations
    • minor cuts
    • scrapes
    • minor skin irritations
    • rashes due to poison ivy, poison oak, oak, and sumac
  • dries the oozing and weeping of poison ivy, poison oak, and poison sumac

Warnings

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use

  • on large areas of the body
  • with any other product containing diphenhydramine, even one taken by mouth

OTC - ASK DOCTOR SECTION

Ask a doctor before use

  • on chicken pox
  • on measles

OTC - WHEN USING SECTION

When using this product

  • use only as directed
  • avoid contact with eyes

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • condition worsens or does not improve within 7 days
  • symptoms persist for 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

  • adults and children 2 years of age and over: apply to affected area not more than 3 to 4 times daily
  • children under 2 years of age: consult a physician

Other information

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

cetyl alcohol, di sodium edetate, Diazolidinyl urea, methylparaben, peg-100 stearate, peg-2 stearate, petrolatum, potassium hydroxide, polyethylene glycol, propylparaben, stearic acid, water

Questions?

OTC - QUESTIONS SECTION

toll-free 866-326-1313

TheraCare Extra Strength Anti-Itch Cream

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabelPackPack

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1087026diphenhydrAMINE HCl 2 % / zinc acetate 0.1 % Topical CreamPSN3
1087026diphenhydramine hydrochloride 20 MG/ML / zinc acetate 1 MG/ML Topical CreamSCD3
1087026diphenhydramine hydrochloride 2 % / zinc acetate 0.1 % Topical CreamSY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIPHENHYDRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71101-215-012025-07-29C16284748780-13b156c62-341a-fb37-e063-e6dba90a4e07TheraCare Extra Strength Anti-Itch Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71101-215-01TheraCare Extra Strength Anti-Itch CreamItch Stopping1 in 1 CARTONCREAM13
71101-215-01TheraCare Extra Strength Anti-Itch CreamItch Stopping35.4 g in 1 TUBECREAM35.43

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71101-215THERACARE EXTRA STRENGTH ANTI-ITCH CREAM ITCH STOPPING (DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE) CREAM [VERIDIAN HEALTHCARE]3Legacy NDC, 2 package rows20241220_cb1ab983-4598-d5c0-e053-2a95a90aee09.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71101-21571101-215-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
EDETATE SODIUMMP1J8420LUIACT
PEG-2 STEARATE94YQ11Y95FIACT
STEARIC ACID4ELV7Z65APIACT
METHYLPARABENA2I8C7HI9TIACT
PETROLATUM4T6H12BN9UIACT
POLYOXYL 100 STEARATEYD01N1999RIACT
POTASSIUM HYDROXIDEWZH3C48M4TIACT
CETYL ALCOHOL936JST6JCNIACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
ZINC ACETATEFM5526K07AACTIB

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
29950bd9-5029-a8d3-e063-6394a90a9f16cb1ab983-4598-d5c0-e053-2a95a90aee092024-12-18WarningsExact identifier
spl id: 29950bd9-5029-a8d3-e063-6394a90a9f16
spl set id: cb1ab983-4598-d5c0-e053-2a95a90aee09

Reported adverse events (FAERS/openFDA)#

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