Top Care 336.002/336AF Medicated Calamine Lotion

Manufacturer: Topco associates LLC | Consumer Product Partners, LLC
Effective date: 2024-07-31
Label type: HUMAN OTC DRUG LABEL
Version: 11
Source: legacy-cache
Hydrated at: 2026-08-01 20:57:35

Label at a glance#

ProductCalamine

Active ingredientFERRIC OXIDE RED, PRAMOXINE HYDROCHLORIDE

Label structure13 sections

Dosage and administration

shake well before applying was affected are of skin Adults and children 2 years of age and older - apply to affected area not more than 3 to 4 times daily Children under 2 years of age - do not use, ask a doctor

Contacts and useful links#

PhoneLabel contact1-888-423-0139

Websitewww.topcarebrand.com

www.topcarebrand.com

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Calamine 8%

Pramoxind HCl 1%

Purpose

OTC - PURPOSE SECTION

Skin protectant

External analgesic

Use

INDICATIONS & USAGE SECTION

for the temporary relief of pain and itching associated with minot skin irritations and rashes due to poison ivy, poison oak, or poison sumac
dries the oozing and weeping of poison:
ivy
oak
sumac

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

do not get into eyes

Stop use and ask a doctor

OTC - STOP USE SECTION

condition worsens
symptoms last more than 7 days or clean up and occur again within 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 applying was affected are of skin

Adults and children 2 years of age and older - apply to affected area not more than 3 to 4 times daily

Children under 2 years of age - do not use, ask a doctor

Other information

SPL UNCLASSIFIED SECTION

store at room temperature (59°-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

alcohol, camphor, diazolidinyl urea, fragrance, hypromellose, methylparaben, oil of lavender, oil of rosemary, polysorbate 80, propylene glycol, propylparaben, purified water, xanthan gum

Dislcaimer

SPL UNCLASSIFIED SECTION

This product is not manufactured or distributed by Valeant Pharmaceuticals, distributor of Caladryl Lotion

Adverse reactions

ADVERSE REACTIONS SECTION

DIST. BY TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL

@TOPCO VIJA071

QUESTIONS? 1-888-423-0139

topcare@topco.coM

www.topcarebrand.com

336.002/336AF

principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TopCare

Health

COMPARE TO

CALADRYL LOTION

ACTIVE INGREDIENTS

MEDICATED

Calamine

Lotion

EXTERANAL ANALGESIC/

SKIN PROTECTANT

Drying Action Plus

Itch Relief for:

Poison Ive, Oak & Sumac

OUR PHARMACISTS RECOMMEND

6 FL OZ (177 mL)

image description

RxCUI, Display, Full name table
RxCUI	Display	Full name	Type	Form / route
1234532	Calamine/Pramoxine (Topical)	calamine 80 MG/ML / pramoxine hydrochloride 10 MG/ML Topical Lotion	SCD Active

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
36800-336-30	ML - Milliliter	36800-336	25bd9fa9-8b00-428a-b5c2-02d6a1c4b32d	1	2015-07-20

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
DIAZOLIDINYL UREA	INACTIVE INGREDIENT	H5RIZ3MPW4	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	1
LAVENDER OIL	INACTIVE INGREDIENT	ZBP1YXW0H8	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	1
ROSEMARY OIL	INACTIVE INGREDIENT	8LGU7VM393	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	1

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

Calamine
Calamine, Pramoxind HCl
ALCOHOL
CAMPHOR (NATURAL)
DIAZOLIDINYL UREA
HYPROMELLOSES
METHYLPARABEN
LAVENDER OIL
ROSEMARY OIL
POLYSORBATE 80
PROPYLENE GLYCOL
PROPYLPARABEN
WATER
XANTHAN GUM
FERRIC OXIDE RED
PRAMOXINE HYDROCHLORIDE
PRAMOXINE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
36800-336	36800-336-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ALCOHOL	3K9958V90M	IACT
CAMPHOR (NATURAL)	N20HL7Q941	IACT
DIAZOLIDINYL UREA	H5RIZ3MPW4	IACT
HYPROMELLOSES	3NXW29V3WO	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
LAVENDER OIL	ZBP1YXW0H8	IACT
ROSEMARY OIL	8LGU7VM393	IACT
POLYSORBATE 80	6OZP39ZG8H	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
PROPYLPARABEN	Z8IX2SC1OH	IACT
WATER	059QF0KO0R	IACT
XANTHAN GUM	TTV12P4NEE	IACT
FERRIC OXIDE RED	1K09F3G675	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 8 · 426 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	POWDER, FOR SUSPENSION / ORAL		8 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	AEROSOL, FOAM / TOPICAL	0.98 %w/w		Exact identifier — unii candidate 78 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	INJECTION, EMULSION / INTRAVENOUS		520 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / RECTAL	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		6 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	AEROSOL, FOAM / TOPICAL		4504 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	SUSPENSION / RECTAL		452 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SOLUTION / AURICULAR (OTIC)	0.2 %w/w		Exact identifier — unii candidate 78 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	AEROSOL, METERED / RESPIRATORY (INHALATION)		26664 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	CONCENTRATE / BUCCAL	679 mg/1ml		Exact identifier — unii candidate 59 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / ORAL		27120 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	TABLET, EXTENDED RELEASE / ORAL	0.17 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	ELIXIR / ORAL	200 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	PASTE / ORAL		28 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	JELLY / VAGINAL	NA		Exact identifier — unii candidate 59 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	FILM, SOLUBLE / BUCCAL		5 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	OINTMENT / RECTAL		27 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SUSPENSION / SUBCUTANEOUS	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SYSTEM / TOPICAL		28 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / INTRAVENOUS	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	GEL / TOPICAL		4522 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SYRUP / ORAL		40 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	TABLET, COATED / ORAL	0.8 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUSPENSION / AURICULAR (OTIC)	NA		Exact identifier — unii candidate 79 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	CREAM / TOPICAL		20 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / EPIDURAL	1 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SPRAY, METERED / NASAL	0.1 mg/1ml		Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SOLUTION / INTRAVENOUS		900 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, SUSPENSION / INTRAVENOUS	0.5 %w/v		Exact identifier — unii candidate 78 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	EMULSION / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	FILM, SOLUBLE / BUCCAL		1 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	CAPSULE / ORAL	418.37 mg		Exact identifier — unii candidate 78 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	FILM / BUCCAL		1 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / INFILTRATION	0.35 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	AEROSOL, METERED / RECTAL	NA		Exact identifier — unii candidate 81 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	GEL / DENTAL	1.8 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	LIQUID / RESPIRATORY (INHALATION)	10 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	CONCENTRATE / INTRAVENOUS		4680 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUSPENSION, EXTENDED RELEASE / ORAL		40 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION / INTRAVENOUS		4680 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	CREAM / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 27 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SUSPENSION / ORAL		64 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	POWDER, FOR SOLUTION / ORAL	10 mg/5ml		Exact identifier — unii candidate 29 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	SUSPENSION / ORAL		360 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	AEROSOL / TOPICAL		561 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	INJECTION / INTRAMUSCULAR		1491 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	SUSPENSION / OPHTHALMIC		2 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	CREAM / VAGINAL	0.4 %w/w		Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SOLUTION/ DROPS / AURICULAR (OTIC)		13 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	ELIXIR / ORAL	800 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, SUSPENSION / SUBCUTANEOUS	0.3 %w/v		Exact identifier — unii candidate 78 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	CONCENTRATE / ORAL	198 mg		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	AEROSOL, SPRAY / TOPICAL		561 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION, SOLUTION / INTRAVENOUS		4000 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	LOTION / TOPICAL	25 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	TABLET, ORALLY DISINTEGRATING / ORAL		1 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 81 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL		2350 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET, CHEWABLE / ORAL	11.8 mg		Exact identifier — unii candidate 27 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION/ DROPS / OPHTHALMIC	0.01 %w/v		Exact identifier — unii candidate 68 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
27e98c3e-e66f-5bc9-e063-6394a90ac594			f08cf654-d884-4e12-b008-4caf7d9d33e2	2024-11-27	Warnings, Adverse reactions	Exact identifier spl set id: f08cf654-d884-4e12-b008-4caf7d9d33e2

Reported adverse events (FAERS/openFDA)#

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