Freskaro Calamine Clear

Manufacturer: Pharma Nobis, LLC
Effective date: 2026-04-15
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-06-01 01:53:55

Label at a glance#

ProductCalamine Clear

Active ingredientPRAMOXINE HYDROCHLORIDE, ZINC ACETATE

Label structure11 sections

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-833-551-0932

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Pramoxine HCl 1%

Zinc Acetate 0.1%

OTC - PURPOSE SECTION

External Analgesic & Skin Protectant

INDICATIONS & USAGE SECTION

Dries the oozing and weeping, and temporarily relieves pain and itching of poison ivy, poison oak, and poison sumac or other minor skin irritations.

WARNINGS SECTION

For external use only. Use only as directed.

Avoid contact with eyes and mucous membranes

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center (1-800-222-1222) right away.

DOSAGE & ADMINISTRATION SECTION

Adults and children 2 years of age and older: Shake well before using. Cleanse the skin with soap and water and let dry before each use. Apply lotion fo the affected area using cotton or soft cloth, not more than 3 to 4 times daily as needed for comfort.
Children under 2 years of age: do not use, consult a doctor.

Other information

OTHER SAFETY INFORMATION

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

INACTIVE INGREDIENT SECTION

SD Alcohol 38B 2.5%, Camphor, Diazolidinyl Usea, Fragrances, Glycerin, Hydroxypropyl Methylcellulose, Methylparaben, Polysorbate 80, Propylene Glycol, Propylparaben, Purified Water

Questions or comments?

OTC - QUESTIONS SECTION

1-833-551-0932

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Freskaro Calamine Clear 2026

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1234546	pramoxine HCl 1 % / zinc acetate 0.1 % Topical Lotion	PSN	1
1234546	pramoxine hydrochloride 10 MG/ML / zinc acetate 1 MG/ML Topical Lotion	SCD	1
1234546	pramoxine HCl 1 % / zinc acetate 0.1 % 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	0382645400965	GTIN-13: 0382645400965 EAN-13: 0382645400965 GTIN-12: 382645400965 UPC-A: 382645400965 GTIN storage (14 digits): 00382645400965	Freskaro Calamine Clear 4 15 2026.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
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8	Product name	1	20140508
a7051cba-790b-a699-81f8-dbbbdbd9b5ac	Product name	1	20140508
da108d9e-edc8-17a3-8c28-3251c6a8accc	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
82645-400-96	Calamine Clear	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 · 16 matching rows.

Calamine Clear
Pramoxine Hydrochloride and Zinc Acetate Lotion
DIAZOLIDINYL UREA
POLYSORBATE 80
CAMPHOR (NATURAL)
ALCOHOL
GLYCERIN
HYPROMELLOSE, UNSPECIFIED
METHYLPARABEN
PROPYLENE GLYCOL
WATER
PROPYLPARABEN
PRAMOXINE HYDROCHLORIDE
PRAMOXINE
ZINC ACETATE
ZINC CATION

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
82645-400	82645-400-96

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
DIAZOLIDINYL UREA	H5RIZ3MPW4	IACT
POLYSORBATE 80	6OZP39ZG8H	IACT
CAMPHOR (NATURAL)	N20HL7Q941	IACT
ALCOHOL	3K9958V90M	IACT
GLYCERIN	PDC6A3C0OX	IACT
HYPROMELLOSE, UNSPECIFIED	3NXW29V3WO	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
WATER	059QF0KO0R	IACT
PROPYLPARABEN	Z8IX2SC1OH	IACT
PRAMOXINE HYDROCHLORIDE	88AYB867L5	ACTIB
ZINC ACETATE	FM5526K07A	ACTIB

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 Clear	PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE LOTION	Pharma Nobis, LLC	4f853183-5925-2c73-e063-6394a90adf6c	2026-04-15	Warnings	Exact identifier ndc (package): 82645-400-96 ndc (product): 82645-400 ndc11 (package): 82645040096 spl id: 4f852c10-3978-1f04-e063-6394a90a5c1d spl set id: 4f853183-5925-2c73-e063-6394a90adf6c

Reported adverse events (FAERS/openFDA)#

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