Calamine Skin Protectant Cream

SPL v3

SPL

SPL Set ID 2c7b23a1-76cb-095e-e063-6294a90ac6f2

Route

TOPICAL

Published

Effective Date 2025-02-14

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Zinc Oxide (21 g) Menthol (0.44 g)

Inactive Ingredients

Phenol Glycerin Thymol White Petrolatum Sodium Bicarbonate Mineral Oil Lanolin Ferric Oxide Red

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-04-01

Description

Menthol 0.44% Zinc Oxide 20.625%

Medication Information

Description

Menthol 0.44% Zinc Oxide 20.625%

Use

A moisture barrier that prevents and helps heal skin irritations from:

• Urine • Diarrhea • Perspiration • Fistula drainage • Feeding tube site leakage • Wound drainage (peri-wound skin) • Minor burns • Cuts • Scrapes • Itching

Warnings

For external use only

Directions

• Cleanse skin with mild skin cleanser.

• Pat dry or allow to air dry.

• Apply a thin layer of PROSKI SOOTHE to reddened or irritated skin 2-4 times daily, or after each incontinent episode or diaper change to promote comfort and long-lasting protection.

Do Not Use

• On deep or puncture wounds

Indication

External Analgesic

Skin Protectant

Active Ingredient

Menthol 0.44%

Zinc Oxide 20.625%

Other Information

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

• Tamper evident. Do not use if packet is torn or cut. Do not use if seal is damaged.

Inactive Ingredients

Ferric Oxide Red, Glycerin, Lanolin, Mineral Oil, Phenol, Sodium Bicarbonate, Thymol, White Petrolatum

Questions Or Comments?

(754)-200-8994 (Mon-Fri 8 AM to 4 PM EST)

When Using This Product

• Avoid contact with eyes

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

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Package/label Principal Display Panel

NDC: 84289-234-01

CALAMINE SKIN PROTECTANT CREAM

Protects, Soothes

Enhanced Formula

Net Wt 4 oz. (113 g)

GOA/DRUGS/571

Structured Label Content

Use (USE)

A moisture barrier that prevents and helps heal skin irritations from:

• Urine • Diarrhea • Perspiration • Fistula drainage • Feeding tube site leakage • Wound drainage (peri-wound skin) • Minor burns • Cuts • Scrapes • Itching

Warnings (WARNINGS)

For external use only

Directions (DIRECTIONS)

• Cleanse skin with mild skin cleanser.

• Pat dry or allow to air dry.

• Apply a thin layer of PROSKI SOOTHE to reddened or irritated skin 2-4 times daily, or after each incontinent episode or diaper change to promote comfort and long-lasting protection.

Do Not Use (Do not use)

• On deep or puncture wounds

Indication (INDICATION)

External Analgesic

Skin Protectant

Active Ingredient (ACTIVE INGREDIENT)

Menthol 0.44%

Zinc Oxide 20.625%

Other Information (OTHER INFORMATION)

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

• Tamper evident. Do not use if packet is torn or cut. Do not use if seal is damaged.

Inactive Ingredients (INACTIVE INGREDIENTS)

Ferric Oxide Red, Glycerin, Lanolin, Mineral Oil, Phenol, Sodium Bicarbonate, Thymol, White Petrolatum

Questions Or Comments? (QUESTIONS OR COMMENTS?)

(754)-200-8994 (Mon-Fri 8 AM to 4 PM EST)

When Using This Product (When using this product)

• Avoid contact with eyes

Stop Use and Ask A Doctor If (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

Keep Out of Reach of Children (Keep out of reach of children)

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Package/label Principal Display Panel (PACKAGE/LABEL PRINCIPAL DISPLAY PANEL)

NDC: 84289-234-01

CALAMINE SKIN PROTECTANT CREAM

Protects, Soothes

Enhanced Formula

Net Wt 4 oz. (113 g)

GOA/DRUGS/571

Advanced Ingredient Data

[{"name": "PHENOL", "unii": "339NCG44TV", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "THYMOL", "unii": "3J50XA376E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WHITE PETROLATUM", "unii": "B6E5W8RQJ4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BICARBONATE", "unii": "8MDF5V39QO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MINERAL OIL", "unii": "T5L8T28FGP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LANOLIN", "unii": "7EV65EAW6H", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ZINC OXIDE", "unii": "SOI2LOH54Z", "classCode": "ACTIB", "strengthNumerator": "21", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "MENTHOL", "unii": "L7T10EIP3A", "classCode": "ACTIB", "strengthNumerator": "0.44", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "FERRIC OXIDE RED", "unii": "1K09F3G675", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"USE": "A moisture barrier that prevents and helps heal skin irritations from: • Urine • Diarrhea • Perspiration • Fistula drainage • Feeding tube site leakage • Wound drainage (peri-wound skin) • Minor burns • Cuts • Scrapes • Itching", "WARNINGS": "For external use only", "DIRECTIONS": "• Cleanse skin with mild skin cleanser. • Pat dry or allow to air dry. • Apply a thin layer of PROSKI SOOTHE to reddened or irritated skin 2-4 times daily, or after each incontinent episode or diaper change to promote comfort and long-lasting protection.", "Do not use": "• On deep or puncture wounds", "INDICATION": "External Analgesic Skin Protectant", "ACTIVE INGREDIENT": "Menthol 0.44% Zinc Oxide 20.625%", "OTHER INFORMATION": "• Store at room temperature 15º-30º C (59º-86º F) • Tamper evident. Do not use if packet is torn or cut. Do not use if seal is damaged.", "INACTIVE INGREDIENTS": "Ferric Oxide Red, Glycerin, Lanolin, Mineral Oil, Phenol, Sodium Bicarbonate, Thymol, White Petrolatum", "QUESTIONS OR COMMENTS?": "(754)-200-8994 (Mon-Fri 8 AM to 4 PM EST)", "When using this product": "• Avoid contact with eyes", "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", "Keep out of reach of children": "If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.", "PACKAGE/LABEL PRINCIPAL DISPLAY PANEL": "NDC: 84289-234-01 CALAMINE SKIN PROTECTANT CREAM Protects, Soothes Enhanced Formula Net Wt 4 oz. (113 g) GOA/DRUGS/571"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:05:49.505206 · Updated: 2026-03-14T23:08:10.789867