Indications and uses
for the temporary relief of local itching and discomfort in the perianal area temporarily protects irritated areas for the temporary relief of pain may provide a cooling sensation
Medline Remedy Phytoplex Calazime
- Manufacturer
- Medline Industries, LP
- Effective date
- 2024-01-29
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 7
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 21:12:16
Label at a glance#
ProductMedline Remedy Phytoplex Calazime
Active ingredientZINC OXIDE, PETROLATUM, MENTHOL
Label structure9 sections
Dosage and administration
adults: Cleanse the affected area by patting or blotting with an appropriate cleansing pad. Gently dry by patting or blotting with toilet tissue or a soft cloth. Apply product externally to the affected area up to 6 times daily. children under 12 years of age: consult a doctor
Storage and handling
Protect from freezing. Avoid excessive heat.
Contacts and useful links#
Websitewww.medline.com
www.medline.com
www.medline.comLabel contents#
Full prescribing information#
Active Ingredients
- Menthol 0.44%
- White Petrolatum 53%
- Zinc Oxide 20.6%
Purpose
- External Analgesic, Anti-itch
- Protectant
- Protectant
Uses
- for the temporary relief of local itching and discomfort in the perianal area
- temporarily protects irritated areas
- for the temporary relief of pain
- may provide a cooling sensation
Warnings
- For external use only
- Avoid contact with eyes
When using this product
- do not place into the rectum with fingers or any device or applicator
- keep out of reach of children
Stop use and ask a doctor if
- condition worsens or does not improve within 7 days
- bleeding occurs
- an allergic reaction develops with symptoms such as redness, irritation, or pain
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
OVERDOSAGE SECTION
- Do not exceed the recommended daily dosage unless directed by a doctor.
- Certain persons can develop allergic reactions to ingredients in this product. If the symptoms being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase, discontinue use and consult a doctor.
Directions
- adults: Cleanse the affected area by patting or blotting with an appropriate cleansing pad. Gently dry by patting or blotting with toilet tissue or a soft cloth. Apply product externally to the affected area up to 6 times daily.
- children under 12 years of age: consult a doctor
Inactive ingredients
7-dehydrocholesterol, algae extract (aphanizomenon flos-aquae), beeswax, bisabolol, brassica campestris (rapeseed) sterols, calamine, camellia sinensis (green tea) leaf extract, caprylic/capric triglycerides, carthamus tinctorius (safflower) seed oil, cetylhydroxyproline palmitamide, cholecalciferol, cocos nucifera (coconut) oil, corn starch, dimethicone, eugenia caryophyllus (clove) flower extract, glycerin, hexyldecanol, hydrolyzed soy protein, manuka honey, olea europaea (olive) oil, phospholipids, phytonadione, simmondsia chinensis (jojoba) seed oil, stearic acid, tocopheryl acetate, water, yeast ferment extract, zea mays (corn) oil, zea mays (corn) starch.
Other information
Protect from freezing. Avoid excessive heat.
Manufacturing Information
Manufactured for Medline Industries, LP
Three Lakes Drive, Northfield, IL 60093 USA
1-800-MEDLINE
REF: MSC092554
RH19PUA
Package Labels
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 53329-105-44 | GM - Gram | 53329-105 | 56e05dfd-798e-4caa-a0bd-666739d41dbe | 1 | 2023-04-07 |
Products#
Every source-derived product name is available through these pages.
- Medline Remedy Phytoplex Calazime
- menthol, zinc oxide, petrolatum
- ZINC OXIDE
- PETROLATUM
- MENTHOL
- STEARIC ACID
- OLIVE OIL
- STARCH, CORN
- HEXYLDECANOL
- .ALPHA.-TOCOPHEROL ACETATE, D-
- PHYTONADIONE
- YEAST
- EGG PHOSPHOLIPIDS
- RAPESEED STEROL
- WATER
- LEVOMENOL
- CETYLHYDROXYPROLINE PALMITAMIDE
- GREEN TEA LEAF
- FERRIC OXIDE RED
- NORI
- COCONUT OIL
- DIMETHICONE 100
- HONEY
- JOJOBA OIL
- CHOLECALCIFEROL
- CORN OIL
- HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW)
- 7-DEHYDROCHOLESTEROL
- CAPRYLYL GLYCOL
- WHITE WAX
- SAFFLOWER OIL
- GLYCERIN
- CLOVE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 53329-105 | 53329-105-44, 53329-105-87, 53329-105-96, 53329-105-14 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 101b73d7-7130-311b-e063-6294a90afd67 | 6dd75810-da93-28aa-e053-2a91aa0a0dab | 2024-01-29 | Warnings | 101b73d7-7130-311b-e063-6294a90afd67 6dd75810-da93-28aa-e053-2a91aa0a0dab |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.