Humco Calaclear

Manufacturer: Humco Holding Group, Inc. | Pharma Nobis, LLC
Effective date: 2023-12-15
Label type: HUMAN OTC DRUG LABEL
Version: 7
Source: full-release
Hydrated at: 2026-06-01 00:04:36

Label at a glance#

ProductHumco Calaclear

Active ingredientPRAMOXINE HYDROCHLORIDE, ZINC ACETATE

Label structure11 sections

Dosage and administration

Adults and children 2 yrs. of age and older. Shake well before using. Cleanse the skin with soap and water and let dry before each use. Apply lotion to 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: Consult a doctor before use.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Humco Calamine Lotion

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Pramoxine HCl 1%

Purpose

OTC - PURPOSE SECTION

External Analgesic

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Acetate 0.1%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Use

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

WARNINGS SECTION

For external use only. Use only as directed.

Avoid contact with eyes and mucous membranes.

Ask a doctor before using

OTC - ASK DOCTOR SECTION

on children under 2 years of age.

When using this product. Discontinue use if

OTC - WHEN USING SECTION

condition worsens, does not improve or if symptoms persist for more than 7 days, or clear up and occur again within a few days. and consult a doctor.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 2 yrs. of age and older. Shake well before using. Cleanse the skin with soap and water and let dry before each use. Apply lotion to 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: Consult a doctor before use.

Other Information

OTHER SAFETY INFORMATION

store at room temperature 15 ^o – 30 ^oC (50 ^o – 85 ^oF)

Inactive Ingredient

INACTIVE INGREDIENT SECTION

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

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Calaclear.jpgPRINCIPAL DISPLAY PANEL NDC 0395-0400-96 CALACLEARTM Lotion 6 FL OZ (177 mL)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1248193	CALACLEAR 1 % / 0.1 % Topical Lotion	PSN	7
1234546	pramoxine HCl 1 % / zinc acetate 0.1 % Topical Lotion	PSN	7
1248193	pramoxine hydrochloride 10 MG/ML / zinc acetate 1 MG/ML Topical Lotion [Calaclear]	SBD	7
1234546	pramoxine hydrochloride 10 MG/ML / zinc acetate 1 MG/ML Topical Lotion	SCD	7
1248193	Calaclear (pramoxine hydrochloride 1 % / zinc acetate 0.1 % ) Topical Lotion	SY	7
1234546	pramoxine HCl 1 % / zinc acetate 0.1 % Topical Lotion	SY	7

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0395-0400-96	Humco Calaclear	177 mL in 1 BOTTLE, PLASTIC	LOTION	177		7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0395-0400	HUMCO CALACLEAR (PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE) LOTION [HUMCO HOLDING GROUP, INC.]	7	Current NDC, Legacy NDC, 1 package rows	20231216_5fca3a73-6d66-496b-bd33-6e044f9039bc.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0395-0400-96	ML - Milliliter	0395-0400	5d47f9f0-f8d2-4b5e-a5bf-5e5ef8a7de71	1	2014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
PRAMOXINE HYDROCHLORIDE	ACTIVE INGREDIENT	88AYB867L5	1
ZINC OXIDE	ACTIVE INGREDIENT	SOI2LOH54Z	1
PRAMOXINE	ACTIVE MOIETY	068X84E056	1
ZINC CATION	ACTIVE MOIETY	13S1S8SF37	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	1
CAMPHOR (NATURAL)	INACTIVE INGREDIENT	N20HL7Q941	1
DIAZOLIDINYL UREA	INACTIVE INGREDIENT	H5RIZ3MPW4	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

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

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0395-0400	0395-0400-96

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

Source Document#

Source XML

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 · 14 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	LOTION / TOPICAL		351 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	LOTION / TOPICAL	15 %w/w		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	LOTION / TOPICAL		140 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	LOTION / TOPICAL		3392 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
DIAZOLIDINYL UREA	DIAZOLIDINYL UREA	H5RIZ3MPW4	LOTION / TOPICAL	3 %w/w		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	LOTION / TOPICAL	25 %w/w		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	LOTION / TOPICAL	15 %w/w		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	LOTION / TOPICAL		351 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	LOTION / TOPICAL		3990 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	LOTION / TOPICAL	25 %w/w		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	LOTION / TOPICAL		140 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	LOTION / TOPICAL		3392 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
DIAZOLIDINYL UREA	DIAZOLIDINYL UREA	H5RIZ3MPW4	LOTION / TOPICAL	3 %w/w		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	LOTION / TOPICAL		3990 mg	Exact identifier — unii+route+dosage form 2 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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Humco Calaclear	PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE	Humco Holding Group, Inc.	5fca3a73-6d66-496b-bd33-6e044f9039bc	2023-12-15	Warnings	Exact identifier ndc (package): 0395-0400-96 ndc (product): 0395-0400 ndc11 (package): 00395040096 spl id: 0c929258-b193-bc2f-e063-6394a90a8e47 spl set id: 5fca3a73-6d66-496b-bd33-6e044f9039bc

Reported adverse events (FAERS/openFDA)#

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