FDA.reportPublic FDA data

Calprotect Ointment

Manufacturer
Reliable 1 Laboratories LLC
Effective date
2026-02-19
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:46:32

Label at a glance#

ProductCalprotect
Active ingredientZINC OXIDE, MENTHOL
Label structure10 sections

Indications and uses

A moisture barrier that prevents and helps heal skin irritations from urine diarrhea perspiration fistula drainage feeding tube site leakage wound drainage (per-wound skin) minor burns cuts scrapes itching

Dosage and administration

Cleanse skin gently with mild skin cleanser. Pat dry or allow to air dry. Apply a thin layer of Calprotect Ointment to reddened or irritated skin 2-4 times daily, or after each incontinent episode or diaper change to promote comfort and long lasting protection.

Storage and handling

Store between 15-30°C (59-86°F)

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Menthol 0.44%

Zinc Oxide 20.6%

Purpose

OTC - PURPOSE SECTION

External analgesic / Anti-itch

Skin protectant / Anorectal astrigent

Uses

INDICATIONS & USAGE SECTION

A moisture barrier that prevents and helps heal skin irritations from

  • urine
  • diarrhea
  • perspiration
  • fistula drainage
  • feeding tube site leakage
  • wound drainage (per-wound skin)
  • minor burns
  • cuts
  • scrapes
  • itching

Warnings

WARNINGS SECTION

For external use only

  • Not for deep or puncture wounds
  • Avoid contact with eyes
  • Incase of accidental ingestion, contact a physician or posion contril immediately
  • If condition worsens or does not improve in 7 days, consult a doctor
  • Do not put this product into the rectum by using fingers or any machanical device or applicator
  • Children under 12 years of age: consult a doctor

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

Directions

DOSAGE & ADMINISTRATION SECTION

Cleanse skin gently with mild skin cleanser. Pat dry or allow to air dry. Apply a thin layer of Calprotect Ointment to reddened or irritated skin 2-4 times daily, or after each incontinent episode or diaper change to promote comfort and long lasting protection.

Other information

STORAGE AND HANDLING SECTION

Store between 15-30°C (59-86°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

calamine, chlorothymol, glycerin, lanolin, phenol, sodium bicarbonate, and thymol in a suitable ointment base

Questions or comments?

OTC - QUESTIONS SECTION

1-516-341-0666 8:30 am-4:30 pm EST Mon-Fri

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Protects, Soothes & Promotes Healing

NDC 69618-067-82

Compare to active ingredients in Calmoseptine*

CalProtect Ointment

External use only

Made in the USA

*Reliable-1 Labs is not affiliated with the owner of the registered trademark Calmoseptine

Calprotect 113g TubeCalprotect 113g Tube

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2702497CalProtect 0.44 % / zinc oxide 20.6 % Topical OintmentPSN5
2123045menthol 0.44 % / zinc oxide 20.6 % Topical OintmentPSN5
2702497menthol 0.0044 MG/MG / zinc oxide 0.206 MG/MG Topical Ointment [Calprotect]SBD5
2123045menthol 0.0044 MG/MG / zinc oxide 0.206 MG/MG Topical OintmentSCD5
2702497Calprotect (menthol 0.44 % / zinc oxide 20.6 % ) Topical OintmentSY5
2123045Menthol 0.0044 MG/MG / ZNO 0.206 MG/MG Topical OintmentSY5
2702497menthol 0.0044 MG/MG / ZNO 0.206 MG/MG Topical Ointment [Calprotect]SY5
2123045menthol 0.44 % / zinc oxide 20.6 % Topical OintmentSY5

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130369618067820GTIN-13: 0369618067820
EAN-13: 0369618067820
GTIN-12: 369618067820
UPC-A: 369618067820
GTIN storage (14 digits): 00369618067820		Calprotect 113g Tube.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69618-067-71Calprotect71 g in 1 JAROINTMENT715
69618-067-82Calprotect113 g in 1 TUBEOINTMENT1135

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69618-067-71GM - Gram69618-0674d28b714-56c8-4898-a629-9c8e2cde284312023-12-05
69618-067-82GM - Gram69618-0672549dd69-0e5c-435a-aa71-3b84f4ead93512023-12-05

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69618-06769618-067-82, 69618-067-71

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
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIB
PHENOL339NCG44TVIACT
FERRIC OXIDE RED1K09F3G675IACT
CHLOROTHYMOLLJ25TI0CVTIACT
MENTHOLL7T10EIP3AACTIB
GLYCERINPDC6A3C0OXIACT
THYMOL3J50XA376EIACT
LANOLIN7EV65EAW6HIACT
SODIUM BICARBONATE8MDF5V39QOIACT

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CalprotectMENTHOL, ZINC OXIDEReliable 1 Laboratories LLC09fb2810-0cc1-b2e2-e063-6294a90a45762026-02-19WarningsExact identifier
ndc (package): 69618-067-82
ndc (package): 69618-067-71
ndc (product): 69618-067
ndc11 (package): 69618006771
ndc11 (package): 69618006782
spl id: 4b32706a-c97a-589c-e063-6294a90abc11
spl set id: 09fb2810-0cc1-b2e2-e063-6294a90a4576

Reported adverse events (FAERS/openFDA)#

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