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

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

Purpose

Skin Protectant

Description

Calamine 8% Zinc oxide 8%

Medication Information

Warnings

For external use only

Purpose

Skin Protectant

Directions

shake well before using
apply as needed

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

Inactive Ingredients

bentonite magma, calcium hydroxide, glycerin, purified water

Description

Calamine 8% Zinc oxide 8%

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)

Questions?

1-888-593-0593

Use

dries the oozing and weeping of poison:

ivy
oak
sumac

Active Ingredients

Calamine 8%

Zinc oxide 8%

When Using This Product

Do not get into 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 right away.

Structured Label Content

Warnings

For external use only

Purpose

Skin Protectant

Directions

shake well before using
apply as needed

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

Inactive Ingredients (Inactive ingredients)

bentonite magma, calcium hydroxide, glycerin, purified water

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)

Questions?

1-888-593-0593

Use

dries the oozing and weeping of poison:

ivy
oak
sumac

Active Ingredients (Active ingredients)

Calamine 8%

Zinc oxide 8%

When Using This Product (When using this product)

Do not get into 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 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