Calamine Clear

Manufacturer: Cardinal Health, 110 dba Leader
Effective date: 2024-05-13
Label type: HUMAN OTC DRUG LABEL
Version: 5
Source: full-release
Hydrated at: 2026-06-01 00:12:24

Label at a glance#

ProductCalamine Clear

Active ingredientPRAMOXINE HYDROCHLORIDE, ZINC ACETATE

Label structure8 sections

Contacts and useful links#

PhonePoison Help1-800-222-1222

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

Temporarily Relieves Pain and Itching Associated with:

rashes due to poison ivy, poison oak, or poison sumac
insect bites
minor skin irritation
minor cuts
dries the oozing and weeping of poison ivy, poison oak and poison sumac

WARNINGS SECTION

For external use only. Use only as directed.

Acoid contact with eyes and mucous membranes

Ask a doctor before using on children under 2 years of age.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately (1-800-222-1222)

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 dialy as needed for comfort.

INACTIVE INGREDIENT SECTION

SD Alcohol 38B 2.5%

Camphor

Diazolidinyl Usea

Fragrances

Glycerin

Hydroxypropyl Methylcellulose

Methylparaben

Polysorbate 80

Propylene Glycol

Propylparaben

Purified Water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

calclear

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	5
1234546	pramoxine hydrochloride 10 MG/ML / zinc acetate 1 MG/ML Topical Lotion	SCD	5
1234546	pramoxine HCl 1 % / zinc acetate 0.1 % Topical Lotion	SY	5

DailyMed Pharmacologic Classes#

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

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
70000-0397-1	2024-05-13	C162847	48780-1	1030e365-5d48-111a-e063-dadaa90a10e2	Leader Calamine Clear
70000-0397-1	2024-01-30	C162847	48780-1	1030e365-5d48-111a-e063-dadaa90a10e2	Leader Calamine Clear

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70000-0397-1	Calamine Clear	177 mL in 1 BOTTLE, PLASTIC	LOTION	177		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70000-0397	CALAMINE CLEAR (PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE LOTION) LOTION [CARDINAL HEALTH, 110 DBA LEADER]	5	Current NDC, Legacy NDC, 1 package rows	20240514_7f733c0a-82b2-d3b0-e053-2991aa0a6b0f.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70000-0397-1	ML - Milliliter	70000-0397	5fb31edf-544b-4024-92d9-17c966d2e953	1	2019-08-06

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
70000-0397	70000-0397-1

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	Cardinal Health, 110 dba Leader	7f733c0a-82b2-d3b0-e053-2991aa0a6b0f	2024-05-13	Warnings	Exact identifier ndc (package): 70000-0397-1 ndc (product): 70000-0397 ndc11 (package): 70000039701 spl id: 185584d0-0662-431c-e063-6394a90a4827 spl set id: 7f733c0a-82b2-d3b0-e053-2991aa0a6b0f

Reported adverse events (FAERS/openFDA)#

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