FDA.reportPublic FDA data

Rite Aid 063.001/063AA Calamine Lotion

Manufacturer
Rite Aid | Consumer Product Partners, LLC
Effective date
2024-11-05
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 20:50:23

Label at a glance#

ProductCalamine
Active ingredientFERRIC OXIDE RED, ZINC OXIDE
Label structure12 sections

Dosage and administration

shake well before using apply as needed

Storage and handling

store at 59⁰ - 86⁰ F

Label contents#

Full prescribing information#

Active ingredents

OTC - ACTIVE INGREDIENT SECTION

Calamine 8%
Zinc oxide 8%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Use

INDICATIONS & USAGE SECTION

dries the oozing and weeping of poison:•ivy • oak • sumac

Warnings

WARNINGS SECTION

For external use only

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

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away

Directions

DOSAGE & ADMINISTRATION SECTION

  • shake well before using
  • apply as needed

Other information

STORAGE AND HANDLING SECTION

store at 59⁰ - 86⁰ F

Inactive ingredients

INACTIVE INGREDIENT SECTION

bentonite magma, calcium hydroxide, glycerin, purified water

Adverse Reaction

ADVERSE REACTIONS SECTION

DISTRIBUTED BY: RITE AID

200 NEWBERRY COMMONS

ETTERS, PA 17319

www.riteaid.com

SATISFACTION GUARANTEE:

If you're not satisfied, we'll happily refund your money.

principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CALAMINE LOTION

CALAMINE TOPICAL SUSPENSION USP

SKIN PROTECTANT

Dries the oozing & weeping of poison ivy, poison oak & poison sumac

6 FL OZ (177 mL)

image descriptionimage description

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-0630CALAMINE (FERRIC OXIDE RED) LOTION [RITE AID]1Unmatched20241106_2859d99f-9aff-4ae5-9507-7fc2326639ac.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11822-063011822-0630-1

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
BENTONITEA3N5ZCN45CIACT
CALCIUM HYDROXIDEPF5DZW74VNIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
FERRIC OXIDE RED1K09F3G675ACTIB
ZINC OXIDESOI2LOH54ZACTIB

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
3c30068b-74f0-f3bb-e063-6294a90a2b102859d99f-9aff-4ae5-9507-7fc2326639ac2025-08-12Warnings, Adverse reactionsExact identifier
spl set id: 2859d99f-9aff-4ae5-9507-7fc2326639ac

Reported adverse events (FAERS/openFDA)#

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