Dr. Simi Calamine

Manufacturer: Farmacias De Similares TX LLC | Pharma Nobis, LLC
Effective date: 2026-04-06
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-06-01 01:52:58

Label at a glance#

ProductCalamine

Active ingredientFERRIC OXIDE RED, ZINC OXIDE

Label structure10 sections

Indications and uses

Dries the oozing and weeping of poison: ■ ivy ■ oak ■ sumac

Dosage and administration

■ Adults and children of 2 years of age and older: Shake well before using. Cleanse the skin with soap and water and dry the area before application. Apply lotion to the affected area using cotton or soft cloth, as often as needed for comfort. ■ Children under 2 years of age: Consult a doctor before use.

Contacts and useful links#

PhoneLabel contact(855)-280-1079

Websitewww.drsimi.com

www.drsimi.com

Label contents#

Full prescribing information#

Drug Facts Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Calamine 8%
Zinc Oxide 8%

Purpose

OTC - PURPOSE SECTION

Calamine 8%,

Zinc Oxide 8%

Skin protectant

Uses

INDICATIONS & USAGE SECTION

Dries the oozing and weeping of poison:
■ ivy
■ oak
■ sumac

Warnings

WARNINGS SECTION

■ For external use only

■ Use only as directed

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

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

■ Adults and children of 2 years of age and older: Shake well before using. Cleanse the skin with soap and water and dry the area before application. Apply lotion to the affected area using cotton or soft cloth, as often as needed for comfort.

■ Children under 2 years of age: Consult a doctor before use.

Other information

OTHER SAFETY INFORMATION

Store at room temperature 15° - 30°C (59° - 86°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Avicel, bentonite magma, calcium hydroxide, carrageenan, glycerin, purified water, and xanthan gum.

Questions or comments?

OTC - QUESTIONS SECTION

(855)-280-1079

Principal Display Panel

SPL UNCLASSIFIED SECTION

NDC: 85786-703-06

DR. SIMI

Calamine Lotion

Calamine
Topical Suspension

Skin Protectant

Poison Ivy, Oak, and Sumac Drying Lotion

6 fl oz (177 mL)

WARNING: DO NOT USE IF TAMPER EVIDENT SEAL UNDER CAP IS BROKEN OR MISSING.

Distributed by:
FARMACIAS DE SIMILARES TX LLC
800 Brazos St Ste 260, Austin, TX, 78701, USA
customerservice@drsimi.com
www.drsimi.com

Immediate container labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Immediate container labeling

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
617954	calamine 8 % / zinc oxide 8 % Topical Lotion	PSN	1
617954	calamine 80 MG/ML / zinc oxide 80 MG/ML Topical Lotion	SCD	1
617954	calamine 8 % / zinc oxide 8 % Topical Lotion	SY	1
617954	Calamine 80 MG/ML / ZNO 80 MG/ML Topical Lotion	SY	1

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
ZINC CATION Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	EAN-13	0199961000065	GTIN-13: 0199961000065 EAN-13: 0199961000065 GTIN-12: 199961000065 UPC-A: 199961000065 GTIN storage (14 digits): 00199961000065	Calamine - PDP .jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f47a510b-6679-4664-b2d6-47b5c4afe7cc	Product name	4	20260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61c	Product name	2	20250515
0306390c-dd77-4363-afe0-63c58088b2a1	Product name	1	20220120
503ea967-4b9c-48cf-9e87-c7975295849d	Product name	2	20220120
190f2a5b-bbc8-65c7-fcb0-97891307b917	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
85786-703-06	Calamine	177 mL in 1 BOTTLE, PLASTIC	LOTION	177		1

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

Calamine
Calamine 8%, Zinc Oxide 8%
MICROCRYSTALLINE CELLULOSE
WATER
CARRAGEENAN
CALCIUM HYDROXIDE
BENTONITE
XANTHAN GUM
GLYCERIN
FERRIC OXIDE RED
ZINC OXIDE
ZINC CATION

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
85786-703	85786-703-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IACT
WATER	059QF0KO0R	IACT
CARRAGEENAN	5C69YCD2YJ	IACT
CALCIUM HYDROXIDE	PF5DZW74VN	IACT
BENTONITE	A3N5ZCN45C	IACT
XANTHAN GUM	TTV12P4NEE	IACT
GLYCERIN	PDC6A3C0OX	IACT
FERRIC OXIDE RED	1K09F3G675	ACTIB
ZINC OXIDE	SOI2LOH54Z	ACTIM

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Calamine	CALAMINE 8%, ZINC OXIDE 8%	Farmacias De Similares TX LLC	4ecd0add-11c9-cf3b-e063-6394a90adff6	2026-04-06	Warnings	Exact identifier ndc (package): 85786-703-06 ndc (product): 85786-703 ndc11 (package): 85786070306 spl id: 4ecd0add-11ca-cf3b-e063-6394a90adff6 spl set id: 4ecd0add-11c9-cf3b-e063-6394a90adff6

Reported adverse events (FAERS/openFDA)#

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