L-Topical CALAMINE 8% PRAMOXINE HCL 1% 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 22:47:21

Label at a glance#

ProductL-Topical CALAMINE 8% PRAMOXINE HCL 1%
Active ingredientZINC OXIDE, PRAMOXINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

• Temporarily relieves pain and itching associated with: • Rashes due to poison ivy, • Poison oak or poison sumac • Insect bites • Minor skin irritation • Minor cuts • Dries the oozing and weeping of poison ivy, poison oak and poison sumac

Dosage and administration

• Shake well before use • Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily • Children under 2 years of age: ask a doctor

Storage and handling

Store at 20° to 25°C (68° to 77°F)

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Calamine 8%
Pramoxine HCl 1%

Purpose

OTC - PURPOSE SECTION

Skin protectant
Topical analgesic

USES

INDICATIONS & USAGE SECTION

• Temporarily relieves pain and itching associated with:
• Rashes due to poison ivy, • Poison oak or poison sumac • Insect bites • Minor skin irritation • Minor cuts • Dries the oozing and weeping of poison ivy, poison oak and poison sumac

WARNINGS

WARNINGS SECTION

For external use only.

When using this product do not get into eyes

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.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

• Shake well before use • Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily • Children under 2 years of age: ask a doctor

OTHER INFORMATION

STORAGE AND HANDLING SECTION

Store at 20° to 25°C (68° to 77°F)

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

SD Alcohol 38-B, Camphor, Diazolidinyl urea, Fragrance, Hypromellose, Methylparaben, Polysorbate 80, Propylene glycol, Propylparaben, Purified water, Xanthan gum

QUESTIONS/COMMENTS

OTC - QUESTIONS SECTION

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

SPL UNCLASSIFIED SECTION

Calamine Plus Itch Reliever

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

Calamine Pramoxine HCl-1Calamine Pramoxine HCl-1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73921-036-042023-02-08C16284748780-1f386c649-c150-0266-e053-dadaa90a7c1aL-Topical CALAMINE 8% PRAMOXINE HCL 1% LOTION
73921-036-042023-01-30C16284748780-1f386c649-c150-0266-e053-dadaa90a7c1aL-Topical CALAMINE 8% PRAMOXINE HCL 1% LOTION

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73921-03673921-036-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 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
f42ad874-1142-1ea4-e053-2995a90a9e035dd9a3f3-227b-440e-8867-3e0187f860932023-02-08WarningsExact identifier
spl set id: 5dd9a3f3-227b-440e-8867-3e0187f86093

Reported adverse events (FAERS/openFDA)#

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