Skin Protectant Ointment with Calamine

Manufacturer: Gentell LLC
Effective date: 2026-08-19
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: daily-update
Hydrated at: 2026-08-21 02:01:48

Label at a glance#

ProductClaraVie

Active ingredientZINC OXIDE, MENTHOL

Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Menthol 0.44% w/w

Zinc Oxide 20.625% w/w

OTC - PURPOSE SECTION

External Analgesic

Skin Protectant

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 right away.

INACTIVE INGREDIENT SECTION

Calamine, Glycerin, Lanolin, Light liquid Paraffin, Petrolatum, Thymol, Tocopheryl Acetate

WARNINGS SECTION

For external use only

Not for deep or puncture wounds
Avoid contact with eyes

OTC - ASK DOCTOR SECTION

Stop use and ask a doctor if

Condition worsens
Symptoms last more than 7 days or clear up and occur again within a few days

DOSAGE & ADMINISTRATION SECTION

Apply as recommended

INDICATIONS & USAGE SECTION

A moisture barrier that prevents & helps heal skin irritation from :

urine
diarrhea
perspiration
fistula drainage
feeding tube site leakage
wound drainage (peri-wound skin)
minor burn
cuts
scrapes
itching

OTC - QUESTIONS SECTION

Store at room temperature 68-77 ⁰ F (20-25 ⁰ C)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANELPACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	EAN-13	0361554012636	GTIN-13: 0361554012636 EAN-13: 0361554012636 GTIN-12: 361554012636 UPC-A: 361554012636 GTIN storage (14 digits): 00361554012636	Skin Protectant Ointment with Calamine 4oz_Tube_Page_2.jpg

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

ClaraVie
Menthol, Zinc Oxide
ZINC OXIDE
MENTHOL
GLYCERIN
LANOLIN
LIGHT MINERAL OIL
PETROLATUM
THYMOL
.ALPHA.-TOCOPHEROL ACETATE, D-
FERRIC OXIDE RED

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
61554-306	61554-306-11, 61554-306-21

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ZINC OXIDE	SOI2LOH54Z	ACTIB
MENTHOL	L7T10EIP3A	ACTIB
GLYCERIN	PDC6A3C0OX	IACT
LANOLIN	7EV65EAW6H	IACT
LIGHT MINERAL OIL	N6K5787QVP	IACT
PETROLATUM	4T6H12BN9U	IACT
THYMOL	3J50XA376E	IACT
.ALPHA.-TOCOPHEROL ACETATE, D-	A7E6112E4N	IACT
FERRIC OXIDE RED	1K09F3G675	IACT

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
ClaraVie	MENTHOL, ZINC OXIDE	Gentell LLC	596c467f-a056-ea78-e063-6394a90a79f2	2026-08-19	Warnings	Exact identifier ndc (package): 61554-306-21 ndc (package): 61554-306-11 ndc (product): 61554-306 ndc11 (package): 61554030611 ndc11 (package): 61554030621 spl id: 596c467f-a057-ea78-e063-6394a90a79f2 spl set id: 596c467f-a056-ea78-e063-6394a90a79f2

Reported adverse events (FAERS/openFDA)#

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