Quality Choice 063.001/063aa

SPL v3

SPL

SPL Set ID 86ff4875-9007-4b7b-8f46-16cbd475d4bb

Route

TOPICAL

Published

Effective Date 2025-02-26

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 2025-02-26

Description

Calamine 8% Zinc oxide 8%

Purpose

Skin Protectant

Medication Information

Purpose

Skin Protectant

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

Adverse Reaction

Distributed by CMDA, Inc.

Novi, MI 48375

www.qualitychoice.com

Questions: 800-935-2362

SATISFACTION GUARANTEED

100% QC

Other Information

store at 59⁰ - 86⁰ F

Active Ingredients

Calamine 8%

Zinc oxide 8%

Inactive Ingredients

bentonite magma, calcium hydroxide, glycerin, purified water

Principal Display Panel

NDC 83324-248-06

QUALITY CHOICE

Calamine

Lotion

Calamine Topical Suspension USP

Skin Protectant

Dries the Oozing and Weeping of Poison:

Ivy, Oak & Sumac

6 FL OZ (177 mL)

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

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 (ADVERSE REACTION)

Distributed by CMDA, Inc.

Novi, MI 48375

www.qualitychoice.com

Questions: 800-935-2362

SATISFACTION GUARANTEED

100% QC

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

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 83324-248-06

QUALITY CHOICE

Calamine

Lotion

Calamine Topical Suspension USP

Skin Protectant

Dries the Oozing and Weeping of Poison:

Ivy, Oak & Sumac

6 FL OZ (177 mL)

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": "Distributed by CMDA, Inc. Novi, MI 48375 www.qualitychoice.com Questions: 800-935-2362 SATISFACTION GUARANTEED 100% QC", "Other information": "store at 59⁰ - 86⁰ F", "Active ingredients": "Calamine 8% Zinc oxide 8%", "Inactive ingredients": "bentonite magma, calcium hydroxide, glycerin, purified water", "PRINCIPAL DISPLAY PANEL": "NDC 83324-248-06 QC QUALITY CHOICE Calamine Lotion Calamine Topical Suspension USP Skin Protectant Dries the Oozing and Weeping of Poison: Ivy, Oak & Sumac 6 FL OZ (177 mL)", "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."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:38.200317 · Updated: 2026-03-14T23:14:00.268297