rexall 063.001/063aa

SPL v19

SPL

SPL Set ID c38c77fd-abbf-4c87-a9c0-a0e21ed3f97d

Route

topical

Published

Effective Date 2025-04-11

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 2009-04-13

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

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

Since 1903

REXALL ^®

Calamine Lotion

Calamine Topical Suspension USP

Skin Protectant

• Poison ivy, oak and sumac drying lotion

6 FL OZ (177 mL)

Use

dries the oozing and weeping of poison:

ivy
oak
sumac

Adverse Reaction

Visit us at: Rexall.com

or call 1-866-4REXALL

DISTRIBUTED BY OLD EAST MAIN CO.

100 MISSION RIDGE

GOODLETTSVILLE, TN 37072

Since 1903 Rexall is a registered trademark of Rexall Sundown, Inc.

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

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)

Since 1903

REXALL ^®

Calamine Lotion

Calamine Topical Suspension USP

Skin Protectant

• Poison ivy, oak and sumac drying lotion

6 FL OZ (177 mL)

Use

dries the oozing and weeping of poison:

ivy
oak
sumac

Adverse Reaction (ADVERSE REACTION)

Visit us at: Rexall.com

or call 1-866-4REXALL

DISTRIBUTED BY OLD EAST MAIN CO.

100 MISSION RIDGE

GOODLETTSVILLE, TN 37072

Since 1903 Rexall is a registered trademark of Rexall Sundown, Inc.

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", "ADVERSE REACTION": "Visit us at: Rexall.com or call 1-866-4REXALL DISTRIBUTED BY OLD EAST MAIN CO. 100 MISSION RIDGE GOODLETTSVILLE, TN 37072 Since 1903 Rexall is a registered trademark of Rexall Sundown, Inc.", "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": "Since 1903 REXALL ® Calamine Lotion Calamine Topical Suspension USP Skin Protectant • Poison ivy, oak and sumac drying lotion 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: 2026-02-15T12:05:53.810479 · Updated: 2026-03-14T23:14:02.652954