Major 063.001 063aa

SPL v6

SPL

SPL Set ID 326f3d80-c1bf-4cf0-a662-58e02ed7ee67

Route

TOPICAL

Published

Effective Date 2025-02-12

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Ferric Oxide Red (8 g) Zinc Oxide (8 mg)

Inactive Ingredients

Bentonite Calcium Hydroxide Glycerin Water

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2018-04-19

Description

Calamine 8% Zinc oxide 8%

Purpose

Skin Protectant

Adverse Reactions

Distributed By: MAJOR PHARMACEUTICALS 17177 N LAUREL PARK DRIVE, SUITE 233 Livonia, MI 48152 Re-Order No 014282 M-97 Rev. 10/16 Relabeled By: Preferred Pharmaceuticals Inc.

Medication Information

Purpose

Skin Protectant

Adverse Reactions

Distributed By:

MAJOR PHARMACEUTICALS

17177 N LAUREL PARK DRIVE, SUITE 233

Livonia, MI 48152

Re-Order No 014282 M-97

Rev. 10/16

Relabeled By: Preferred Pharmaceuticals Inc.

Description

Calamine 8% Zinc oxide 8%

Use

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

Warnings

For external use only

Directions

•
shake well before using
•
apply as needed

Active Ingredents

Calamine 8%

Zinc oxide 8%

Other Information

store at 59⁰ - 86⁰ F

Inactive Ingredients

bentonite magma, calcium hydroxide, glycerin, purified water

Questions Or Comments?

(800) 616-2471

When Using This Product

Do not get into eyes

Principal Display Panel

NDC 68788-0292-1

MAJOR

Calamine

Lotion

Calamine Topical Suspension USP

Skin Protectant

Poison Ivy, Oak, Sumac

Drying Lotion

Shake well before using

6 FL OZ (177 mL)

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 right away

Structured Label Content

Use

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

Purpose

Skin Protectant

Warnings

For external use only

Directions

•
shake well before using
•
apply as needed

Active Ingredents (Active ingredents)

Calamine 8%

Zinc oxide 8%

Adverse Reactions (Adverse reactions)

Distributed By:

MAJOR PHARMACEUTICALS

17177 N LAUREL PARK DRIVE, SUITE 233

Livonia, MI 48152

Re-Order No 014282 M-97

Rev. 10/16

Relabeled By: Preferred Pharmaceuticals Inc.

Other Information (Other information)

store at 59⁰ - 86⁰ F

Inactive Ingredients (Inactive ingredients)

bentonite magma, calcium hydroxide, glycerin, purified water

Questions Or Comments? (Questions or comments?)

(800) 616-2471

When Using This Product (When using this product)

Do not get into eyes

Principal Display Panel (principal display panel)

NDC 68788-0292-1

MAJOR

Calamine

Lotion

Calamine Topical Suspension USP

Skin Protectant

Poison Ivy, Oak, Sumac

Drying Lotion

Shake well before using

6 FL OZ (177 mL)

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 right away

Advanced Ingredient Data

[{"name": "FERRIC OXIDE RED", "unii": "1K09F3G675", "classCode": "ACTIB", "strengthNumerator": "8", "strengthDenominator": "1", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "ZINC OXIDE", "unii": "SOI2LOH54Z", "classCode": "ACTIB", "strengthNumerator": "8", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "BENTONITE", "unii": "A3N5ZCN45C", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CALCIUM HYDROXIDE", "unii": "PF5DZW74VN", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Use": "dries the oozing and weeping of poison:•ivy • oak • sumac", "Purpose": "Skin Protectant", "Warnings": "For external use only", "Directions": "• shake well before using • apply as needed", "Active ingredents": "Calamine 8% Zinc oxide 8%", "Adverse reactions": "Distributed By: MAJOR PHARMACEUTICALS 17177 N LAUREL PARK DRIVE, SUITE 233 Livonia, MI 48152 Re-Order No 014282 M-97 Rev. 10/16 Relabeled By: Preferred Pharmaceuticals Inc.", "Other information": "store at 59⁰ - 86⁰ F", "Inactive ingredients": "bentonite magma, calcium hydroxide, glycerin, purified water", "Questions or comments?": "(800) 616-2471", "When using this product": "Do not get into eyes", "principal display panel": "NDC 68788-0292-1 MAJOR Calamine Lotion Calamine Topical Suspension USP Skin Protectant Poison Ivy, Oak, Sumac Drying Lotion Shake well before using 6 FL OZ (177 mL)", "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 right away"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:33.296731 · Updated: 2026-03-14T23:07:31.529158