165 REMEDY Calazime Skin Protectant

Manufacturer
Medline Industries, LP
Effective date
2025-10-30
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
daily-update
Hydrated at
2026-09-11 03:01:04

Label at a glance#

ProductREMEDY Calazime Skin Protectant
Active ingredientFERRIC OXIDE RED, MENTHOL, ZINC OXIDE, PETROLATUM
Label structure9 sections

Indications and uses

Provides temporary relief from skin irritations, itching and discomfort in the perianal area For the temporary relief of pain May provide a cooling sensation

Dosage and administration

Adults Cleanse the affected area with Remedy No-rinse cleanser Gently dry Apply externally to the affected area up to 6 times daily For peri-G tubes, cleanse as directed, apply thin layer and secure with drain sponge or product as directed. Children under 12 years of age Consult a doctor

Storage and handling

Avoid excessive heat. Protect from freezing.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Calamine 3.5%

Menthol 0.2%

White Petrolatum 69%

Zinc Oxide 16.5%

Purpose

OTC - PURPOSE SECTION

Protectant

Analgesic

Protectant

Protectant

Uses

INDICATIONS & USAGE SECTION

  • Provides temporary relief from skin irritations, itching and discomfort in the perianal area
  • For the temporary relief of pain
  • May provide a cooling sensation

Warnings

WARNINGS SECTION

For External Use Only

Do not use

OTC - DO NOT USE SECTION

  • in the eyes
  • on deep or puncture wounds
  • on animal bites
  • on serious burns.

When using this product

OTC - WHEN USING SECTION

  • do not exceed the recommended daily dosage unless directed by a doctor
  • do not put this product into the rectum by using fingers or any mechanical device or applicator
  • Certain persons can develop allergic reactions to ingredients in this product. If the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase, stop use and consult a doctor

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens or does not improved within 7 days
  • you experience bleeding

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • If accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults

  • Cleanse the affected area with Remedy No-rinse cleanser
  • Gently dry
  • Apply externally to the affected area up to 6 times daily
  • For peri-G tubes, cleanse as directed, apply thin layer and secure with drain sponge or product as directed.

Children under 12 years of age

  • Consult a doctor

Other information

STORAGE AND HANDLING SECTION

  • Avoid excessive heat. Protect from freezing.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Juice, Ascorbic Acid, Ascorbyl Palmitate, Carthamus Tinctorius (Safflower) Seed Oil, Cholecalciferol, Citric Acid, Citrus Aurantium Dulcis Peel Oil, Citrus Grandis Peel Oil, Glycine, Helianthus Annuus (Sunflower) Seed Oil, Hydroxytyrosol, L-proline, L-taurine, Methylparaben, Modified Corn Starch, Methylsulfonymethane, N-acetyl-L-cysteine, Niacinamide, Olea Europaea (Olive) Fruit Oil, PEG-8, Pyridoxine Hydrochloride, Retinyl Palmitate, Tapioca Starch Polymethylsilsesquioxane, Tocopherol, Vanillin, Zea Mays (Corn) Oil.

SPL UNCLASSIFIED SECTION

Medline Remedy is a registered trademark of Medline Industries, Inc.
Olivamine is a registered trademark of McCord Research, Inc. Manufactured for
Medline Industries, Inc., Mundelein, IL 60060 www.medline.com
1-800-MEDLINE

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package LabelPackage Label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7b19f89e-0a13-4d4e-a994-a46d39d008b9Product name120251120
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
13c3e0af-2da2-8aec-9e17-1afd680d80c2Product name820221116
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822
f46c867f-cde5-4f14-a7c1-18ae3a6efd1cProduct name120160303
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53329-165-44GM - Gram53329-165a485e81b-8b21-4e4e-83f9-8ba27da044a412013-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
FERRIC OXIDE REDACTIVE INGREDIENT1K09F3G6751
MENTHOLACTIVE INGREDIENTL7T10EIP3A1
PETROLATUMACTIVE INGREDIENT4T6H12BN9U1
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54Z1
FERRIC OXIDE REDACTIVE MOIETY1K09F3G6751
MENTHOLACTIVE MOIETYL7T10EIP3A1
PETROLATUMACTIVE MOIETY4T6H12BN9U1
ZINC OXIDEACTIVE MOIETYSOI2LOH54Z1
.ALPHA.-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ11
ACETYLCYSTEINEINACTIVE INGREDIENTWYQ7N0BPYC1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0X1
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0R1
ASCORBYL PALMITATEINACTIVE INGREDIENTQN83US2B0N1
CHOLECALCIFEROLINACTIVE INGREDIENT1C6V77QF411
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QP1
CITRUS MAXIMA FRUIT RIND OILINACTIVE INGREDIENT8U3877WD441
CORN OILINACTIVE INGREDIENT8470G57WFM1
DIMETHYL SULFONEINACTIVE INGREDIENT9H4PO4Z4FT1
GLYCINEINACTIVE INGREDIENTTE7660XO1C1
HYDROXYTYROSOLINACTIVE INGREDIENTQEU0NE4O901
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9T1
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)INACTIVE INGREDIENT461P5CJN6T1
NIACINAMIDEINACTIVE INGREDIENT25X51I8RD41
OLIVE OILINACTIVE INGREDIENT6UYK2W1W1E1
ORANGE OILINACTIVE INGREDIENTAKN3KSD11B1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQ1
PYRIDOXINE HYDROCHLORIDEINACTIVE INGREDIENT68Y4CF58BV1
SAFFLOWER OILINACTIVE INGREDIENT65UEH262IS1
SUNFLOWER OILINACTIVE INGREDIENT3W1JG795YI1
VANILLININACTIVE INGREDIENTCHI530446X1
VITAMIN A PALMITATEINACTIVE INGREDIENT1D1K0N0VVC1

Products#

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

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53329-16553329-165-44, 53329-165-96, 53329-165-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
92025-01-29full-release2026-06-01 00:53:50

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 6 · 324 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
METHYLPARABENMETHYLPARABENA2I8C7HI9TSOLUTION / TOPICAL216 mgExact identifier — unii+route
56 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TGEL / TOPICAL24 mgExact identifier — unii+route
56 equally ranked IID candidates
OLIVE OILOLIVE OIL6UYK2W1W1ESOLUTION / TOPICAL0.6 %w/wExact identifier — unii+route
12 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQEMULSION / TOPICAL1.2 %w/wExact identifier — unii+route
40 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQSOLUTION / TOPICAL11100 mgExact identifier — unii+route
40 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPEMULSION / TOPICAL0.11 %w/wExact identifier — unii+route
56 equally ranked IID candidates
GLYCINEGLYCINETE7660XO1CINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS10 mgExact identifier — unii candidate
80 equally ranked IID candidates
OLIVE OILOLIVE OIL6UYK2W1W1ESOLUTION / TOPICAL0.6 %w/wExact identifier — unii+route
12 equally ranked IID candidates
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)461P5CJN6TCAPSULE / ORAL107 mgExact identifier — unii candidate
8 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQSPONGE / TOPICALNAExact identifier — unii+route
40 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQAEROSOL, POWDER / TOPICALNAExact identifier — unii+route
40 equally ranked IID candidates
ASCORBYL PALMITATEASCORBYL PALMITATEQN83US2B0NSOLUTION / TOPICALNAExact identifier — unii+route
12 equally ranked IID candidates
GLYCINEGLYCINETE7660XO1CINJECTION / INTRAMUSCULAR68 mgExact identifier — unii candidate
80 equally ranked IID candidates
ORANGE OILORANGE OIL, COLD PRESSEDAKN3KSD11BPOWDER, FOR SUSPENSION / ORAL4 mgExact identifier — unii candidate
24 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOAP / TOPICAL0.5 %w/wExact identifier — unii+route
56 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOAP / TOPICAL0.5 %w/wExact identifier — unii+route
56 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPCREAM / TOPICAL4 mgExact identifier — unii+route
56 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSUSPENSION / TOPICAL0.24 %w/vExact identifier — unii+route
56 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPOINTMENT / TOPICAL1 mgExact identifier — unii+route
56 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPAEROSOL, FOAM / TOPICAL1 mgExact identifier — unii+route
56 equally ranked IID candidates
GLYCINEGLYCINETE7660XO1CTABLET / ORAL163.31 mgExact identifier — unii candidate
80 equally ranked IID candidates
ORANGE OILORANGE OIL, COLD PRESSEDAKN3KSD11BELIXIR / ORAL0.24 mgExact identifier — unii candidate
24 equally ranked IID candidates
ASCORBYL PALMITATEASCORBYL PALMITATEQN83US2B0NCREAM / TOPICAL0.02 %w/wExact identifier — unii+route
12 equally ranked IID candidates
ASCORBYL PALMITATEASCORBYL PALMITATEQN83US2B0NSOLUTION / TOPICALNAExact identifier — unii+route
12 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TCREAM, AUGMENTED / TOPICAL2 mgExact identifier — unii+route
56 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / TOPICAL17 mgExact identifier — unii+route
56 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQLOTION / TOPICAL5 %w/wExact identifier — unii+route
40 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TLOTION / TOPICAL351 mgExact identifier — unii+route
56 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPAEROSOL, FOAM / TOPICAL1 mgExact identifier — unii+route
56 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQSPONGE / TOPICALNAExact identifier — unii+route
40 equally ranked IID candidates
GLYCINEGLYCINETE7660XO1CINJECTABLE, LIPOSOMAL / INTRAVENOUS0.38 %w/vExact identifier — unii candidate
80 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQSWAB / TOPICAL5250 mgExact identifier — unii+route
40 equally ranked IID candidates
GLYCINEGLYCINETE7660XO1CTABLET, CHEWABLE / ORAL267 mgExact identifier — unii candidate
80 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPCREAM / TOPICAL4 mgExact identifier — unii+route
56 equally ranked IID candidates
GLYCINEGLYCINETE7660XO1CINJECTION, SOLUTION / INTRAVENOUS0.42 %w/vExact identifier — unii candidate
80 equally ranked IID candidates
GLYCINEGLYCINETE7660XO1CINJECTABLE, LIPOSOMAL / INTRAVENOUS0.38 %w/vExact identifier — unii candidate
80 equally ranked IID candidates
ORANGE OILORANGE OIL, COLD PRESSEDAKN3KSD11BLIQUID / ORAL50 mgExact identifier — unii candidate
24 equally ranked IID candidates
CORN OILCORN OIL8470G57WFMCREAM / TOPICALNAExact identifier — unii+route
4 equally ranked IID candidates
GLYCINEGLYCINETE7660XO1CINJECTION / INTRAVENOUS200 mgExact identifier — unii candidate
80 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQLIQUID / TOPICAL1 %w/wExact identifier — unii+route
40 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TCREAM, AUGMENTED / TOPICAL2 mgExact identifier — unii+route
56 equally ranked IID candidates
GLYCINEGLYCINETE7660XO1CINJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR40 mgExact identifier — unii candidate
80 equally ranked IID candidates
GLYCINEGLYCINETE7660XO1CINJECTION, POWDER, FOR SOLUTION / INTRADERMAL0.5 mgExact identifier — unii candidate
80 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1SYSTEM / TOPICAL0.1 mgExact identifier — unii+route
8 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQLIQUID / TOPICAL1 %w/wExact identifier — unii+route
40 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSWAB / TOPICAL0.05 %w/wExact identifier — unii+route
56 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQSOLUTION / TOPICAL11100 mgExact identifier — unii+route
40 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQOINTMENT / TOPICAL1950 mgExact identifier — unii+route
40 equally ranked IID candidates
ORANGE OILORANGE OIL, COLD PRESSEDAKN3KSD11BPOWDER, FOR SUSPENSION / ORAL4 mgExact identifier — unii candidate
24 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQCREAM / TOPICAL10 %w/wExact identifier — unii+route
40 equally ranked IID candidates
GLYCINEGLYCINETE7660XO1CINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS10 mgExact identifier — unii candidate
80 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RGEL / TOPICAL7 mgExact identifier — unii+route
8 equally ranked IID candidates
GLYCINEGLYCINETE7660XO1CINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS200 mgExact identifier — unii candidate
80 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION/ DROPS / TOPICAL0.01 %w/vExact identifier — unii+route
56 equally ranked IID candidates
GLYCINEGLYCINETE7660XO1CTABLET, ORALLY DISINTEGRATING / ORAL60 mgExact identifier — unii candidate
80 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPOINTMENT / TOPICAL1 mgExact identifier — unii+route
56 equally ranked IID candidates
GLYCINEGLYCINETE7660XO1CINJECTION, SOLUTION / INTRAVENOUS0.42 %w/vExact identifier — unii candidate
80 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSPRAY / TOPICAL0.2 %w/wExact identifier — unii+route
56 equally ranked IID candidates
GLYCINEGLYCINETE7660XO1CCAPSULE / ORAL62 mgExact identifier — unii candidate
80 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSHAMPOO, SUSPENSION / TOPICAL0.25 %w/vExact identifier — unii+route
56 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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
REMEDY Calazime Skin ProtectantCALAMINE, MENTHOL, WHITE PETROLATUM, ZINC OXIDEMedline Industries, LP1295cfcc-5b61-481b-964b-f53ffd0cb58e2025-10-30WarningsExact identifier
ndc (package): 53329-165-44
ndc (package): 53329-165-96
ndc (package): 53329-165-02
ndc (product): 53329-165
ndc11 (package): 53329016502
ndc11 (package): 53329016596
ndc11 (package): 53329016544
spl id: 42658b90-1277-f5db-e063-6294a90a2460
spl set id: 1295cfcc-5b61-481b-964b-f53ffd0cb58e

Reported adverse events (FAERS/openFDA)#

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