HEB 336.003/336AG Medicated Calamine Lotion

Manufacturer
H E B | Nice-Pak Products, LLC
Effective date
2026-06-15
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
daily-update
Hydrated at
2026-06-18 05:10:12

Label at a glance#

ProductCalamine, Pramoxind HCl
Active ingredientFERRIC OXIDE RED, PRAMOXINE HYDROCHLORIDE
Label structure14 sections

Indications and uses

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

Dosage and administration

shake well  before applying wash affected area 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 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 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 applying wash affected area 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

OTHER SAFETY INFORMATION

store at room temperature 59°–77°F (15°–25°C)

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

Questions?

OTC - QUESTIONS SECTION

1-888-593-0593

Disclaimer

SPL UNCLASSIFIED SECTION

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

Adverse Reactions

ADVERSE REACTIONS SECTION

MADE WITH PRIDE & CARE FOR H-E-B ®

SAN ANTONIO, TX 78204

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to Caladryl ®Calamine Itch Reliever*

H-E-B ®

Medicated Calamine Lotion

External Analgesic/Skin Protectant

  • Relieves itching due to insect bites, poison oak or ivy, or other minor skin irritation

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 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
37808-61637808-616-30

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
Calamine, Pramoxind HClCALAMINE, PRAMOXIND HCLH E B4a7a0b09-d9bc-e752-e063-6394a90a9f2c2026-06-15Warnings, Adverse reactionsExact identifier
ndc (package): 37808-616-30
ndc (product): 37808-616
ndc11 (package): 37808061630
spl id: 544fe61e-3dd0-605b-e063-6294a90a5d77
spl set id: 4a7a0b09-d9bc-e752-e063-6394a90a9f2c

Reported adverse events (FAERS/openFDA)#

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