FDA.reportPublic FDA data

Signature Care_Signature Select 063.001/063AA Calamine Lotion

Manufacturer
Better Living Brands, LLC | Nice-Pak Products, LLC
Effective date
2026-07-16
Label type
HUMAN OTC DRUG LABEL
Version
15
Source
daily-update
Hydrated at
2026-07-18 05:11:31

Label at a glance#

ProductCalamine
Active ingredientFERRIC OXIDE RED, ZINC OXIDE
Label structure13 sections

Dosage and administration

shake well before using apply as needed

Storage and handling

store at 59⁰ - 86⁰ F

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Calamine 8%
Zinc oxide 8%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

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 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 using
  • apply as needed

Other information

STORAGE AND HANDLING SECTION

store at 59⁰ - 86⁰ F

Inactive ingredients

INACTIVE INGREDIENT SECTION

bentonite magma, calcium hydroxide, glycerin, purified water

Adverse Reaction

ADVERSE REACTIONS SECTION

DISTRIBUTED BY: BETTER LIVING BRANDS LLC

P.O. BOX 99, PLEASANTON, CA 94566-0009

‡1-888-723-3929 

LOVE IT OR IT'S ON US‡

smartlabel ®

Scan here for more information

principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 21130-941-30

Signature SELECT™

CALAMINE LOTION

CALAMINE TOPICAL SUSPENSION USP

SKIN PROTECTANT

Poison ivy, oak, sumac drying lotion

6 FL OZ (177 mL)

image descriptionimage description

principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 21130-941-30

Signature Care™

Quality Guaranteed

Calamine Lotion

Calamine Topical Suspension U.S.P.

Skin Protectant

Poison Ivy, Oak, Sumac Drying Lotion

6 FL OZ (177 mL)

image descriptionimage description

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130321130777847GTIN-13: 0321130777847
EAN-13: 0321130777847
GTIN-12: 321130777847
UPC-A: 321130777847
GTIN storage (14 digits): 00321130777847		mm01.jpg

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
FERRIC OXIDE REDACTIVE INGREDIENT1K09F3G6751
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54Z1
FERRIC OXIDE REDACTIVE MOIETY1K09F3G6751
ZINC OXIDEACTIVE MOIETYSOI2LOH54Z1
BENTONITEINACTIVE INGREDIENTA3N5ZCN45C1
CALCIUM HYDROXIDEINACTIVE INGREDIENTPF5DZW74VN1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
WATERINACTIVE INGREDIENT059QF0KO0R1

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
21130-94121130-941-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENTONITEA3N5ZCN45CIACT
CALCIUM HYDROXIDEPF5DZW74VNIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
FERRIC OXIDE RED1K09F3G675ACTIB
ZINC OXIDESOI2LOH54ZACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
142026-02-23full-release2026-06-01 01:47:00

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 12 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
CALCIUM HYDROXIDECALCIUM HYDROXIDEPF5DZW74VNINJECTION / SUBCUTANEOUSADJ PHExact identifier — unii candidate
8 equally ranked IID candidates
BENTONITEBENTONITEA3N5ZCN45CLOTION / TOPICAL5 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CALCIUM HYDROXIDECALCIUM HYDROXIDEPF5DZW74VNSUSPENSION / ORALADJ PHExact identifier — unii candidate
8 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLOTION / TOPICAL3990 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CALCIUM HYDROXIDECALCIUM HYDROXIDEPF5DZW74VNINJECTION / SUBCUTANEOUSADJ PHExact identifier — unii candidate
8 equally ranked IID candidates
CALCIUM HYDROXIDECALCIUM HYDROXIDEPF5DZW74VNCAPSULE, EXTENDED RELEASE / ORAL14 mgExact identifier — unii candidate
8 equally ranked IID candidates
CALCIUM HYDROXIDECALCIUM HYDROXIDEPF5DZW74VNCAPSULE, EXTENDED RELEASE / ORAL14 mgExact identifier — unii candidate
8 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLOTION / TOPICAL3990 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CALCIUM HYDROXIDECALCIUM HYDROXIDEPF5DZW74VNINJECTION / INTRAVENOUS3.7 mgExact identifier — unii candidate
8 equally ranked IID candidates
CALCIUM HYDROXIDECALCIUM HYDROXIDEPF5DZW74VNSUSPENSION / ORALADJ PHExact identifier — unii candidate
8 equally ranked IID candidates
BENTONITEBENTONITEA3N5ZCN45CLOTION / TOPICAL5 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CALCIUM HYDROXIDECALCIUM HYDROXIDEPF5DZW74VNINJECTION / INTRAVENOUS3.7 mgExact identifier — unii candidate
8 equally ranked IID candidates

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
CalamineFERRIC OXIDE REDBetter Living Brands, LLCc7ef0ef3-6861-4b94-af4b-371fee8c1f3d2026-07-16Warnings, Adverse reactionsExact identifier
ndc (package): 21130-941-30
ndc (product): 21130-941
ndc11 (package): 21130094130
spl id: 56bae8dc-ee09-aa0f-e063-6294a90ae8d8
spl set id: c7ef0ef3-6861-4b94-af4b-371fee8c1f3d

Reported adverse events (FAERS/openFDA)#

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