care one 063.001/063aa

SPL v10

SPL

SPL Set ID 7291e175-a9b6-4c47-93ce-227ce11e4599

Route

topical

Published

Effective Date 2025-04-07

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 2013-02-06

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

CAREONE ^®

Calamine

Lotion

CALAMINE TOPICAL

SUSPENSION USP

Skin Protectant

CALAMINE 8%

ZINC OXIDE 8%

POISON IVY, OAK, SUMACK

DRYING LOTION

OUR PHARMACISTS RECOMMEND

6 FL OZ (177 mL)

Use

dries the oozing and weeping of poison:

ivy
oak
sumac

Active Ingredents

Calamine 8%

Zinc oxide 8%

When Using This Product

Do not get into eyes

Adverse Reaction Section

DISTRIBUTED BY FOODHOLD U.S.A., LLC

LANDOVER, MD 20785 1-877-846-9949

2016 S&S BRANDS LLC

QUALITY GUARANTEED OR YOUR MONEY BACK

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)

CAREONE ^®

Calamine

Lotion

CALAMINE TOPICAL

SUSPENSION USP

Skin Protectant

CALAMINE 8%

ZINC OXIDE 8%

POISON IVY, OAK, SUMACK

DRYING LOTION

OUR PHARMACISTS RECOMMEND

6 FL OZ (177 mL)

Use

dries the oozing and weeping of poison:

ivy
oak
sumac

Active Ingredents (Active ingredents)

Calamine 8%

Zinc oxide 8%

When Using This Product (When using this product)

Do not get into eyes

Adverse Reaction Section

DISTRIBUTED BY FOODHOLD U.S.A., LLC

LANDOVER, MD 20785 1-877-846-9949

2016 S&S BRANDS LLC

QUALITY GUARANTEED OR YOUR MONEY BACK

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", "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": "CAREONE ® Calamine Lotion CALAMINE TOPICAL SUSPENSION USP Skin Protectant CALAMINE 8% ZINC OXIDE 8% POISON IVY, OAK, SUMACK DRYING LOTION OUR PHARMACISTS RECOMMEND 6 FL OZ (177 mL)", "Adverse Reaction Section": "DISTRIBUTED BY FOODHOLD U.S.A., LLC LANDOVER, MD 20785 1-877-846-9949 2016 S&S BRANDS LLC QUALITY GUARANTEED OR YOUR MONEY BACK", "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

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:08:34.531386 · Updated: 2026-03-14T23:12:50.471535