FDA.reportPublic FDA data

L-Topical CALAMINE 8% ZINC OXIDE 8% LOTION

Manufacturer
GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED
Effective date
2021-03-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:45:39

Label at a glance#

ProductL-Topical CALAMINE 8% ZINC OXIDE 8%
Active ingredientFERRIC OXIDE RED, ZINC OXIDE
Label structure10 sections

Storage and handling

Store at room temperature 15-30°C (59-86°F).

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Calamine 8% and Zinc Oxide 8%

Purpose

OTC - PURPOSE SECTION

Skin protectant

INDICATIONS & USAGE

INDICATIONS & USAGE SECTION

Dries the oozing and weeping of poison ivy, poison oak, and poison sumac.

WARNINGS

WARNINGS SECTION

• For external use only. Use only as directed.
• Avoid contact with eyes and mucous membranes.
• Ask a doctor before using on children 6 months of age.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN
In case of accidental ingestion, seek professional assistance or contact a Poison Control center immediately.

DOSAGE & ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

• Adults and children 2 years of age and older: shake well before using. Cleanse the skin with soap and water and let it dry before each use. Apply lotion to the affected area using a cotton or soft cloth, as often as needed for comfort.
• Children under 6 months of age: Consult a doctor before use.

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Bentonite magma, Calcium hydroxide, Glycerin, Purified water.

Other information

STORAGE AND HANDLING SECTION

Store at room temperature 15-30°C (59-86°F).

Questions?

OTC - QUESTIONS SECTION

Call toll-free 1-800-572-6632, Weekdays 7:00 AM - 5.30 PM EST.

SPL UNCLASSIFIED SECTION

Soothing calamine lotion

√ Poison Ivy√ Poison Oak√ Poison Sumac

Manufactured by :

Global Pharma Healthcare Pvt. Ltd.,

A-9, SIDCO Pharmaceutical Complex,

Alathur-603 110 - INDIA.

www.global-pharma.com

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Calamine1Calamine1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73921-035-042023-02-08C16284748780-1f386c649-d8ab-0266-e053-dadaa90a7c1aL-Topical CALAMINE 8% ZINC OXIDE 8% LOTION
73921-035-042023-01-30C16284748780-1f386c649-d8ab-0266-e053-dadaa90a7c1aL-Topical CALAMINE 8% ZINC OXIDE 8% LOTION

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
73921-03573921-035-04

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
FERRIC OXIDE RED1K09F3G675ACTIB
ZINC OXIDESOI2LOH54ZACTIB
BENTONITEA3N5ZCN45CIACT
CALCIUM HYDROXIDEPF5DZW74VNIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT

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
f42ac0ee-2d77-1dfb-e053-2995a90aa6560b5065b5-876e-4e72-be58-aa9d5d638a112023-02-08WarningsExact identifier
spl set id: 0b5065b5-876e-4e72-be58-aa9d5d638a11

Reported adverse events (FAERS/openFDA)#

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