Major 063.001/063aa

SPL v15

SPL

SPL Set ID c25be68d-834a-4959-8d47-01ec789406ba

Route

TOPICAL

Published

Effective Date 2025-07-09

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Ferric Oxide Red (80 mg) Zinc Oxide

Inactive Ingredients

Bentonite Calcium Hydroxide Glycerin Water

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2013-01-07

Description

Calamine 8% Zinc oxide 8%

Purpose

Skin Protectant

Adverse Reactions

Distributed By: MAJOR ® PHARMACEUTICALS Indianapolis, IN 46268 (800) 616-2471 www.major-rugby.com Rev. 03/25 M-97 Re-order No. 014283

Medication Information

Purpose

Skin Protectant

Adverse Reactions

Distributed By:

MAJOR ^®PHARMACEUTICALS

Indianapolis, IN 46268

(800) 616-2471

www.major-rugby.com

Rev. 03/25 M-97 Re-order No. 014283

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

Questions?

1-888-593-0593

Other Information

store at 59⁰ - 86⁰ F

Active Ingredients

Calamine 8%

Zinc oxide 8%

Inactive Ingredients

bentonite magma, calcium hydroxide, glycerin, purified water

When Using This Product

Do not get into eyes

Principal Display Panel

NDC 0904-2533-21

MAJOR ^®

Calamine Lotion

Calamine Topical Suspension USP

Calamine 8%, Zinc Oxide 8%

Skin Protectant

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

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

Questions?

1-888-593-0593

Adverse Reactions (Adverse reactions)

Distributed By:

MAJOR ^®PHARMACEUTICALS

Indianapolis, IN 46268

(800) 616-2471

www.major-rugby.com

Rev. 03/25 M-97 Re-order No. 014283

Other Information (Other information)

store at 59⁰ - 86⁰ F

Active Ingredients (Active ingredients)

Calamine 8%

Zinc oxide 8%

Inactive Ingredients (Inactive ingredients)

bentonite magma, calcium hydroxide, glycerin, purified water

When Using This Product (When using this product)

Do not get into eyes

Principal Display Panel (principal display panel)

NDC 0904-2533-21

MAJOR ^®

Calamine Lotion

Calamine Topical Suspension USP

Calamine 8%, Zinc Oxide 8%

Skin Protectant

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

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": "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": ""}, {"name": "FERRIC OXIDE RED", "unii": "1K09F3G675", "classCode": "ACTIB", "strengthNumerator": "80", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "ZINC OXIDE", "unii": "SOI2LOH54Z", "classCode": "ACTIB", "strengthNumerator": "80", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

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", "Questions?": "1-888-593-0593", "Adverse reactions": "Distributed By: MAJOR ® PHARMACEUTICALS Indianapolis, IN 46268 (800) 616-2471 www.major-rugby.com Rev. 03/25 M-97 Re-order No. 014283", "Other information": "store at 59⁰ - 86⁰ F", "Active ingredients": "Calamine 8% Zinc oxide 8%", "Inactive ingredients": "bentonite magma, calcium hydroxide, glycerin, purified water", "When using this product": "Do not get into eyes", "principal display panel": "NDC 0904-2533-21 MAJOR ® Calamine Lotion Calamine Topical Suspension USP Calamine 8%, Zinc Oxide 8% Skin Protectant dries the oozing and weeping of poison: ivy, oak, and sumac 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: 2026-02-15T12:08:32.971669 · Updated: 2026-03-14T23:12:48.425241