top care 063.001/063aa

SPL v22

SPL

SPL Set ID 2b32e720-ac71-4d60-bc06-e28a00f8a450

Route

topical

Published

Effective Date 2025-04-14

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 1991-09-15 Until 2021-05-28

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

NDC 36800-063-30

TopCare _®health

Calamine Lotion USP

CALAMINE TOPICAL SUSPENSION USP

SKIN PROTECTANT

Drying Lotion for:

Poison Ivy, Oak & Sumac

6 FL OZ (177 mL)

Use

dries the oozing and weeping of poison:

ivy
oak
sumac

Adverse Reaction

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL 60007

©TOPCO VIJA0622 QUESTIONS? 1-888-423-0139

[email protected] www.topcarebrand.com

Visit here for more information:

http://topbrnds.com/4901jk

QUALITY GUARANTEED

Active Ingredents

Calamine 8%

Zinc oxide 8%

Questions Or Comments?

1-888-423-0139

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)

NDC 36800-063-30

TopCare _®health

Calamine Lotion USP

CALAMINE TOPICAL SUSPENSION USP

SKIN PROTECTANT

Drying Lotion for:

Poison Ivy, Oak & Sumac

6 FL OZ (177 mL)

Use

dries the oozing and weeping of poison:

ivy
oak
sumac

Adverse Reaction (ADVERSE REACTION)

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL 60007

[email protected] www.topcarebrand.com

Visit here for more information:

http://topbrnds.com/4901jk

QUALITY GUARANTEED

Active Ingredents (Active ingredents)

Calamine 8%

Zinc oxide 8%

Questions Or Comments? (Questions or comments?)

1-888-423-0139

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 TOPCO ASSOCIATES LLC ELK GROVE VILLAGE, IL 60007 ©TOPCO VIJA0622 QUESTIONS? 1-888-423-0139 topcare@topco.com www.topcarebrand.com Visit here for more information: http://topbrnds.com/4901jk QUALITY GUARANTEED", "Active ingredents": "Calamine 8% Zinc oxide 8%", "Other information": "store at 59⁰ - 86⁰ F", "Inactive ingredients": "bentonite magma, calcium hydroxide, glycerin, purified water", "Questions or comments?": "1-888-423-0139", "When using this product": "Do not get into eyes", "principal display panel": "NDC 36800-063-30 TopCare ® health Calamine Lotion USP CALAMINE TOPICAL SUSPENSION USP SKIN PROTECTANT Drying Lotion for: Poison Ivy, Oak & Sumac 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: 2026-02-15T12:05:54.227021 · Updated: 2026-03-14T23:13:40.815212