Core Values 336.003/336AG Calamine Lotion

Manufacturer
Liberty Procurement, Inc | Consumer Product Partners, LLC
Effective date
2024-07-31
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 20:57:23

Label at a glance#

ProductCalamine
Active ingredientFERRIC OXIDE RED, PRAMOXINE HYDROCHLORIDE
Label structure12 sections

Indications and uses

for the temporary relief of pain and itching associated with minot skin irritations and rashes due to poison ivy, poison oak, or poison sumac dries the oozing and weeping of poison: -ivy -oak -sumac

Dosage and administration

shake well before applying was affected are of skin 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 - do not use, ask a doctor

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Calamine 8%

Pramoxine HCl 1%

Purpose

OTC - PURPOSE SECTION

Skin protectant

External analgesic

Uses

INDICATIONS & USAGE SECTION

  • for the temporary relief of pain and itching associated with minot skin irritations and rashes due to poison ivy, poison oak, or poison sumac
  • 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

OTC - STOP USE SECTION

  • condition worsens
  • symptoms last more than 7 days or clean 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 applying was affected are of skin

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 - do not use, ask a doctor

Other information

SPL UNCLASSIFIED SECTION

store at room temperature (59°-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

alcohol, benzyl alcohol, camphor, fragrance, hydroxypropyl methylcellulose, Lavandula angustifolia (lavender) oil, phenoxyethanol, polysorbate 80, propylene glycol, Rosmarinus officinalis (rosemary) leaf oil, water, xanthan gum

SPL UNCLASSIFIED SECTION

Distributed by

Liberty Procurement, Inc.

650 Liberty Ave.

Union, NJ 07083 USA

Visit us at: www.facevalues.com

SATISFACTION GUARANTEED

Or Your Money Back

DSP-TN-15000

DSP-MO-34

SDS-TN-15012

principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CORE VALUES

MEDICATED

Calamine Itch Relief Lotion

EXTERNAL ANALGESIC

SKIN PROTECTANT

Drying action PLUS itch relief

6 FL OZ (177 mL)

image descriptionimage description

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
63940-43663940-436-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 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
35a6485c-3f2f-d53c-e063-6394a90a94870cf438cd-cdaf-4fda-b001-59f53622e4912025-05-21WarningsExact identifier
spl set id: 0cf438cd-cdaf-4fda-b001-59f53622e491

Reported adverse events (FAERS/openFDA)#

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