FDA.reportPublic FDA data

PSP GO! Calamine Lotion

Manufacturer
RW Consumer Products Ltd
Effective date
2019-10-08
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-02 00:08:16

Label at a glance#

ProductPSP GO Calamine
Active ingredientZINC OXIDE
Label structure7 sections

Dosage and administration

Apply as needed

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Calamine 7.6%
Zinc oxide 7.6%

Purpose

OTC - PURPOSE SECTION

Poison ivy, oak, sumac drying

Use

INDICATIONS & USAGE SECTION

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

  • conditions 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

  • Apply as needed

Other Information

SPL UNCLASSIFIED SECTION

  • Do not use if seal around cap is broken or missing.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

bentonite magma, calcium hydroxide, glycerin, purified water

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label5Label5

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69612-00569612-005-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENTONITEA3N5ZCN45CIACT
CALCIUM HYDROXIDEPF5DZW74VNIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
ZINC OXIDESOI2LOH54ZACTIM

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
e078c35c-e34b-47d5-e053-2a95a90a4488243b9f03-50e8-4e84-83bc-54188f04bbcc2022-06-02WarningsExact identifier
spl set id: 243b9f03-50e8-4e84-83bc-54188f04bbcc

Reported adverse events (FAERS/openFDA)#

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