Calamine Plus Pramoxine HCl

Manufacturer: Premier Brands of America Inc.
Effective date: 2024-10-07
Label type: HUMAN OTC DRUG LABEL
Version: 8
Source: legacy-cache
Hydrated at: 2026-08-01 20:53:15

Label at a glance#

ProductCalamine Plus Pramoxine HCl

Active ingredientFERRIC OXIDE RED, ZINC OXIDE, PRAMOXINE HYDROCHLORIDE

Label structure9 sections

Indications and uses

temporarily relieves pain and itching associated with: insect bites rashes minor skin irritations minor cuts dries the oozing and weeping of poison ivy, poison oak and poison sumac

Dosage and administration

shake well before using adults and children 2 years of age and older cleanse the skin with soap and water let dry before use apply as needed to the affected area, not more than 3 or 4 times daily

Contacts and useful links#

PhoneLabel contact1-866-964-0939

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Calamine 8%
Pramoxine HCl 1%

Purpose

OTC - PURPOSE SECTION

Skin protectant
External analgesic

Uses

INDICATIONS & USAGE SECTION

temporarily relieves pain and itching associated with:

insect bites
rashes
minor skin irritations
minor cuts
dries the oozing and weeping of poison ivy, poison oak and poison sumac

Warnings

WARNINGS SECTION

For external use only. Use only as directed. Intentional misuse by deliberately concentrating and inhailing contents can be harmful or fatal.

Flammable:

OTHER SAFETY INFORMATION

Do not use while smoking or near heat or flame. Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120°F.

When using this product

OTC - WHEN USING SECTION

do not get into eyes
ask a doctor before using on children under 2 years of age

Stop use and ask a doctor if

OTC - STOP USE SECTION

conditions worsens
symtomps last more than 7 days or clear up and occur again in 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
adults and children 2 years of age and older
cleanse the skin with soap and water
let dry before use
apply as needed to the affected area, not more than 3 or 4 times daily

Other information

OTHER SAFETY INFORMATION

store between 20° to 25°C (68° to 77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzyl alcohol, camphor, disteardimonium hectorite, fragrance, hydrated silica, isobutane, oleyl alcohol, SD alcohol 40-B, sorbitan trioleate

Questions?

OTC - QUESTIONS SECTION

Call 1-866-964-0939

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Premier
Calamine Plus
No-Touch Spray

External analgesic & skin protectant
Drying action plus itch relief
Ideal for poison ivy/oak/sumac, insect bites, minor skin irritations & cuts

Shake well before using

6.0 FL OZ (177mL)
Net Wt 4.1 OZ (116g)

PB Calamine Spray.jpg

RxCUI, Display, Full name table
RxCUI	Display	Full name	Type	Form / route
1544717	Calamine/Pramoxine (Topical)	calamine 80 MG/ML / pramoxine hydrochloride 10 MG/ML Topical Spray	SCD Active

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
FERRIC OXIDE RED	ACTIVE INGREDIENT	1K09F3G675	1
PRAMOXINE HYDROCHLORIDE	ACTIVE INGREDIENT	88AYB867L5	1
ZINC OXIDE	ACTIVE INGREDIENT	SOI2LOH54Z	1
FERRIC OXIDE RED	ACTIVE MOIETY	1K09F3G675	1
PRAMOXINE	ACTIVE MOIETY	068X84E056	1
ZINC OXIDE	ACTIVE MOIETY	SOI2LOH54Z	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	1
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	1
CAMPHOR (SYNTHETIC)	INACTIVE INGREDIENT	5TJD82A1ET	1
DISTEARDIMONIUM HECTORITE	INACTIVE INGREDIENT	X687XDK09L	1
HYDRATED SILICA	INACTIVE INGREDIENT	Y6O7T4G8P9	1
ISOBUTANE	INACTIVE INGREDIENT	BXR49TP611	1
OLEYL ALCOHOL	INACTIVE INGREDIENT	172F2WN8DV	1
SORBITAN TRIOLEATE	INACTIVE INGREDIENT	QE6F49RPJ1	1

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

Calamine Plus Pramoxine HCl
Calamine Plus No Touch Spray
CAMPHOR (SYNTHETIC)
HYDRATED SILICA
ISOBUTANE
OLEYL ALCOHOL
BENZYL ALCOHOL
SORBITAN TRIOLEATE
DISTEARDIMONIUM HECTORITE
ALCOHOL
FERRIC OXIDE RED
ZINC OXIDE
PRAMOXINE HYDROCHLORIDE
PRAMOXINE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
56104-031	56104-031-41

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CAMPHOR (SYNTHETIC)	5TJD82A1ET	IACT
HYDRATED SILICA	Y6O7T4G8P9	IACT
ISOBUTANE	BXR49TP611	IACT
OLEYL ALCOHOL	172F2WN8DV	IACT
BENZYL ALCOHOL	LKG8494WBH	IACT
SORBITAN TRIOLEATE	QE6F49RPJ1	IACT
DISTEARDIMONIUM HECTORITE	X687XDK09L	IACT
ALCOHOL	3K9958V90M	IACT
FERRIC OXIDE RED	1K09F3G675	ACTIB
ZINC OXIDE	SOI2LOH54Z	ACTIB
PRAMOXINE HYDROCHLORIDE	88AYB867L5	ACTIB

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 3 · 127 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVITARY	8.4 mg		Exact identifier — unii candidate 50 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	INJECTION, SOLUTION / INTRAVENOUS		6405 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	INJECTION, SOLUTION / INTRAVENOUS		400 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	AEROSOL / NASAL	20 mg		Exact identifier — unii candidate 59 equally ranked IID candidates
OLEYL ALCOHOL	OLEYL ALCOHOL	172F2WN8DV	GEL / TOPICAL		150 mg	Exact identifier — unii candidate 7 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	SOLUTION / INTRAVENOUS		242 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	INJECTION, SUSPENSION / INTRASYNOVIAL		18 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	INJECTION / INTRA-ARTERIAL	0.9 %w/v		Exact identifier — unii candidate 50 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	AEROSOL, SPRAY / RESPIRATORY (INHALATION)	35.75 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	INJECTION, EMULSION / INTRAVENOUS		520 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	INJECTION / SOFT TISSUE		23 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION / TOPICAL		2445 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	SUPPOSITORY / RECTAL	129 mg		Exact identifier — unii candidate 50 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	SHAMPOO / TOPICAL	1.25 %w/w		Exact identifier — unii candidate 50 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	TABLET, DELAYED RELEASE / ORAL	NA		Exact identifier — unii candidate 59 equally ranked IID candidates
SORBITAN TRIOLEATE	SORBITAN TRIOLEATE	QE6F49RPJ1	TABLET / ORAL	NA		Exact identifier — unii candidate 5 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	INJECTION / INTRALESIONAL		23 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	INJECTION, SUSPENSION / INTRAMUSCULAR		40 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
ISOBUTANE	ISOBUTANE	BXR49TP611	AEROSOL, FOAM / RECTAL		142 mg	Exact identifier — unii candidate 4 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	SOLUTION / TOPICAL	2 %w/w		Exact identifier — unii candidate 50 equally ranked IID candidates
CAMPHOR (SYNTHETIC)	CAMPHOR (SYNTHETIC)	5TJD82A1ET	DROPS / OPHTHALMIC	NA		Exact identifier — unii candidate 2 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	SOLUTION / ORAL		360 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	INJECTION / SUBCUTANEOUS		90 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION, CONCENTRATE / ORAL	150.68 mg/1ml		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SUSPENSION / RECTAL	0.35 %v/v		Exact identifier — unii candidate 59 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	144 mg		Exact identifier — unii candidate 50 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	GEL / RECTAL		898 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
SORBITAN TRIOLEATE	SORBITAN TRIOLEATE	QE6F49RPJ1	AEROSOL, SPRAY / RESPIRATORY (INHALATION)	0.86 %w/w		Exact identifier — unii candidate 5 equally ranked IID candidates
SORBITAN TRIOLEATE	SORBITAN TRIOLEATE	QE6F49RPJ1	POWDER, FOR SUSPENSION / ORAL		12 mg	Exact identifier — unii candidate 5 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	INJECTION / INTRAVENOUS		1620 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
ISOBUTANE	ISOBUTANE	BXR49TP611	AEROSOL, SPRAY / TOPICAL		4484 mg	Exact identifier — unii candidate 4 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	INJECTION / SUBCONJUNCTIVAL		252 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	INJECTION / INTRACAVITARY	0.01 ml		Exact identifier — unii candidate 50 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION, CONCENTRATE / INTRAVENOUS		4000 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	CAPSULE / ORAL		450 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	GEL / TOPICAL		9971 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
SORBITAN TRIOLEATE	SORBITAN TRIOLEATE	QE6F49RPJ1	AEROSOL, METERED / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 5 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	INJECTION, SUSPENSION / INTRA-ARTICULAR		40 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	INJECTION / INTRAVENOUS	92 %w/v		Exact identifier — unii candidate 59 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 50 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	SOLUTION / INTRAMUSCULAR		54 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	SPRAY / NASAL		5 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	TABLET, DELAYED RELEASE / ORAL	2.31 mg		Exact identifier — unii candidate 50 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	AEROSOL / TOPICAL		561 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	PASTE / DENTAL	1.8 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	INJECTION, EMULSION / INTRAVENOUS		45 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION / OPHTHALMIC	0.5 %w/v		Exact identifier — unii candidate 59 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	LOTION / TOPICAL		4000 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
OLEYL ALCOHOL	OLEYL ALCOHOL	172F2WN8DV	GEL / TRANSDERMAL	1.5 %w/w		Exact identifier — unii candidate 7 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	DROPS / NASAL	10 mg/1ml		Exact identifier — unii candidate 59 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	INJECTION, SOLUTION / INTRAMUSCULAR		500 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	GEL / DENTAL	1.8 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	ELIXIR / ORAL		13675 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	INJECTION, SUSPENSION / INTRALESIONAL		20 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
OLEYL ALCOHOL	OLEYL ALCOHOL	172F2WN8DV	CREAM / TOPICAL	10 %w/w		Exact identifier — unii candidate 7 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION / INTRAVESICAL		7892 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	CAPSULE, EXTENDED RELEASE / ORAL		8 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	144 mg		Exact identifier — unii candidate 50 equally ranked IID candidates
ISOBUTANE	ISOBUTANE	BXR49TP611	AEROSOL, FOAM / TOPICAL	18 %w/w		Exact identifier — unii candidate 4 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SYRUP / ORAL		21000 mg	Exact identifier — unii candidate 59 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
2b22e023-7e51-72c0-e063-6294a90a8104			8ec89d0e-c921-47d3-9b20-cdf403dc66cf	2025-01-07	Warnings	Exact identifier spl set id: 8ec89d0e-c921-47d3-9b20-cdf403dc66cf

Reported adverse events (FAERS/openFDA)#

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