Equaline 336.003/336AG Medicated Calamine Lotion

Manufacturer
United Natural Foods, Inc. dba UNFI | Nice-Pak Products, LLC
Effective date
2026-09-04
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
daily-update
Hydrated at
2026-09-08 02:01:23

Label at a glance#

ProductCalamine
Active ingredientFERRIC OXIDE RED, PRAMOXINE HYDROCHLORIDE
Label structure13 sections

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

Use

INDICATIONS & USAGE SECTION

  • for the temporary relief of pain and itching associated with minor 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 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 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

Disclaimer

SPL UNCLASSIFIED SECTION

*This product is not manufactured or distributed by Bausch Health US, LLA, distributor of Caladryl  Lotion Calamine Plus Itch Reliever.

ADVERSE REACTION

ADVERSE REACTIONS SECTION

Like it or let us make it right.

That's our quality promise.

855-423-2630

DISTRIBUTED BY UNFI

PROVIDENCE, RI 02908 USA

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to Caladryl ®Lotion active ingredients*

NDC 41163-536-30

EQUALINE ®

medicated calamine lotion

external analgesic

skin protectant

drying action

plus itch relief

6 FL OZ (177 mL)

image descriptionimage description

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508

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
41163-53641163-536-30

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

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
72026-02-17full-release2026-06-01 01:45:59

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
CalamineCALAMINE, PRAMOXINE HCLUnited Natural Foods, Inc. dba UNFI0bc1a9b4-1210-4d9a-bbd2-40e9225e86ea2026-09-04Warnings, Adverse reactionsExact identifier
ndc (package): 41163-536-30
ndc (product): 41163-536
ndc11 (package): 41163053630
spl id: 5aa99c82-3d5d-b0a0-e063-6394a90a1b11
spl set id: 0bc1a9b4-1210-4d9a-bbd2-40e9225e86ea

Reported adverse events (FAERS/openFDA)#

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