Signature Care 063.001/063aa

SPL v14

SPL

SPL Set ID c7ef0ef3-6861-4b94-af4b-371fee8c1f3d

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 2015-06-15

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 BETTER LIVING BRANDS LLC

P.O. BOX 99, PLEASANTON, CA 94566-0009

1-888-723-3929 www.betterlivingbrandsLLC.com

QUALITY & SATISFACTION GUARANTEED OR YOUR MONEY BACK

Active Ingredents

Calamine 8%

Zinc oxide 8%

Other Information

store at 59⁰ - 86⁰ F

Inactive Ingredients

bentonite magma, calcium hydroxide, glycerin, purified water

When Using This Product

Do not get into eyes

Principal Display Panel

NDC 21130-941-30

Signature Care™

Quality Guaranteed

Calamine Lotion

Calamine Topical Suspension U.S.P.

Skin Protectant

Poison Ivy, Oak, 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

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

DISTRIBUTED BY BETTER LIVING BRANDS LLC

P.O. BOX 99, PLEASANTON, CA 94566-0009

1-888-723-3929 www.betterlivingbrandsLLC.com

QUALITY & SATISFACTION GUARANTEED OR YOUR MONEY BACK

Active Ingredents (Active ingredents)

Calamine 8%

Zinc oxide 8%

Other Information (Other information)

store at 59⁰ - 86⁰ F

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 21130-941-30

Signature Care™

Quality Guaranteed

Calamine Lotion

Calamine Topical Suspension U.S.P.

Skin Protectant

Poison Ivy, Oak, Sumac Drying Lotion

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", "Adverse Reaction": "DISTRIBUTED BY BETTER LIVING BRANDS LLC P.O. BOX 99, PLEASANTON, CA 94566-0009 1-888-723-3929 www.betterlivingbrandsLLC.com QUALITY & SATISFACTION GUARANTEED OR YOUR MONEY BACK", "Active ingredents": "Calamine 8% Zinc oxide 8%", "Other information": "store at 59⁰ - 86⁰ F", "Inactive ingredients": "bentonite magma, calcium hydroxide, glycerin, purified water", "When using this product": "Do not get into eyes", "principal display panel": "NDC 21130-941-30 Signature Care™ Quality Guaranteed Calamine Lotion Calamine Topical Suspension U.S.P. Skin Protectant Poison Ivy, Oak, 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: 2026-02-15T12:05:54.906232 · Updated: 2026-03-14T23:13:51.825108