FDA.reportPublic FDA data

1271, 1273, 1275 CalaSoothe

Manufacturer
Dynarex Corporation
Effective date
2026-06-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
weekly-update
Hydrated at
2026-07-17 21:43:54

Label at a glance#

ProductCalaSoothe
Active ingredientMENTHOL, ZINC OXIDE, FERRIC OXIDE RED
Label structure11 sections

Indications and uses

• Dries the oozing and weeping of poison: • ivy •oak • sumac • Helps relieve the itching and discomfort associated with anorectal disorders • For the temporary relief of irritation and burning • May provide a cooling sensation

Dosage and administration

• Adults: When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product. Apply to the affected area up to 6 times daily or after each bowel movement. • Children under 12 years of age: Consult a doctor

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Calamine USP 5%

Menthol USP 0.44%

Zinc Oxide USP 20.625%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Anorectal Analgesic

Anorectal Astringent

Uses

INDICATIONS & USAGE SECTION

• Dries the oozing and weeping of poison: • ivy •oak • sumac

• Helps relieve the itching and discomfort associated with anorectal disorders

• For the temporary relief of irritation and burning

• May provide a cooling sensation

Warnings

WARNINGS SECTION

For external use only

Stop use and ask a doctor if

OTC - STOP USE SECTION

• condition worsens or does not improve within 7 days, concult a doctor • bleeding occurs • redness, irritation, swelling, or pain develops or increases

When using this product

OTC - WHEN USING SECTION

• Do not exceed the recommended daily dosage unless directed by a doctor • Certain people 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 symtoms develop or increase, discontinue use and consult a doctor. • Do not put this product into the rectum by using fingers or any mechanical device or applicator

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

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 (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

• Adults: When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product. Apply to the affected area up to 6 times daily or after each bowel movement. • Children under 12 years of age: Consult a doctor

Other information

OTHER SAFETY INFORMATION

• Store at room temperature 15°-30°C (59°-86°F)

• Tamper Evident. Do not use if seal is damaged.

Inactive ingredients

INACTIVE INGREDIENT SECTION

glycerin, lanolin, mineral oil, phenol, sodium bicarbonate, thymol, white petrolatum

Questions?

OTC - QUESTIONS SECTION

1-888-DYNAREX Monday - Friday, 9AM - 5PM EST.

Label 1271

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1271_BX_MASTER1271_BX_MASTER

Label 1273

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1273_IN_MASTER1273_IN_MASTER

Label 1275

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1275_IN_MASTER1275_IN_MASTER

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130616784127125GTIN-13: 0616784127125
EAN-13: 0616784127125
GTIN-12: 616784127125
UPC-A: 616784127125
GTIN storage (14 digits): 00616784127125		1271_BX_MASTER_R260629-1.jpg
BarcodeEAN-130616784127514GTIN-13: 0616784127514
EAN-13: 0616784127514
GTIN-12: 616784127514
UPC-A: 616784127514
GTIN storage (14 digits): 00616784127514		1275_IN_MASTER_R260629-1.jpg
BarcodeEAN-130840117347939GTIN-13: 0840117347939
EAN-13: 0840117347939
GTIN-12: 840117347939
UPC-A: 840117347939
GTIN storage (14 digits): 00840117347939		1273_IN_MASTER_R260629-1.jpg

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67777-24167777-241-01, 67777-241-02, 67777-241-03, 67777-241-04, 67777-241-05, 67777-241-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
THYMOL3J50XA376EIACT
GLYCERINPDC6A3C0OXIACT
WHITE PETROLATUMB6E5W8RQJ4IACT
MENTHOLL7T10EIP3AACTIB
ZINC OXIDESOI2LOH54ZACTIB
SODIUM BICARBONATE8MDF5V39QOIACT
PHENOL339NCG44TVIACT
MINERAL OILT5L8T28FGPIACT
FERRIC OXIDE RED1K09F3G675ACTIB
LANOLIN7EV65EAW6HIACT

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
CalaSootheCALAMINE, MENTHOL, AND ZINC OXIDEDynarex Corporation54f12005-acfe-4821-e063-6394a90ac3042026-06-24WarningsExact identifier
ndc (package): 67777-241-02
ndc (package): 67777-241-06
ndc (package): 67777-241-05
ndc (package): 67777-241-03
ndc (package): 67777-241-04
ndc (package): 67777-241-01
ndc (product): 67777-241
ndc11 (package): 67777024101
ndc11 (package): 67777024104
ndc11 (package): 67777024105
ndc11 (package): 67777024102
ndc11 (package): 67777024106
ndc11 (package): 67777024103
spl id: 54f12005-acff-4821-e063-6394a90ac304
spl set id: 54f12005-acfe-4821-e063-6394a90ac304

Reported adverse events (FAERS/openFDA)#

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