CVS Calamine Plus Roll On

Manufacturer
CVS Pharmacy | Pharma Nobis, LLC
Effective date
2026-09-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-10-03 00:01:49

Label at a glance#

ProductCVS Calamine Plus Roll On
Active ingredientZINC OXIDE, PRAMOXINE HYDROCHLORIDE
Label structure11 sections

Dosage and administration

Adults and children 2 years and older . Shake well before using. Cleanse the skin with soap and water and let dry. Apply to the affected area no more than 3 to 4 times daily as needed for comfort. Children under 2 years of age: Do not use, consult a doctor.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

CVS Calamine Plus

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Calamine 8%

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Pramoxine HCl 1%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Purpose

OTC - PURPOSE SECTION

External Analgesic

Use

INDICATIONS & USAGE SECTION

Dries the oozing and weeping, and temporarily relieves pain and itching of poison ivy, poison oak, poison sumac or other minor skin irritations.

Warnings

WARNINGS SECTION

For external use only. Use only as directed.

Avoid Contact

OTC - WHEN USING SECTION

with eyes and mucous membranes

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens
  • symptoms last for more than 7 days, or clear up and occur again within a few days.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • In case of accidental ingestion, seek professional assistance or contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 2 years and older. Shake well before using. Cleanse the skin with soap and water and let dry. Apply to the affected area no more than 3 to 4 times daily as needed for comfort.
  • Children under 2 years of age: Do not use, consult a doctor.

Other Information

OTHER SAFETY INFORMATION

  • store at room temperature 15 o – 30 oC (59 o – 86 oF)

Inactive Ingredient

INACTIVE INGREDIENT SECTION

SD Alcohol 38B 2.5%, Camphor, Diazolidinyl Urea, Fragrances, Glycerin, Hypromellose, Methylparaben, Polysorbate 80, Propylene Glycol, Propylparaben, and Purified Water.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Calamine Roll On PHCalamine Roll On PH

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51316-42051316-420-97

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 97 · 1,933 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dermaka Infants and Kids Multi Purpose Skin ProtectantZINC OXIDEDermaka Skin Products LLCf84dfd55-db6c-4d75-be67-4d13a139e2092026-09-10WarningsName fallback
generic name: ZINC OXIDE
Zinc OxideZINC OXIDECVS Pharmacy, Inc.35e67726-4527-4cd7-8e73-30325a32402c2026-09-09Warnings, Adverse reactionsName fallback
generic name: ZINC OXIDE
Sunski Hot Block Mineral Sunscreen Stick SPF 50ZINC OXIDEStewart Charley Ventures LLC dba Sunski04ecc5e7-0d9e-4bc7-b964-4cbcc6ed06a82026-09-01WarningsName fallback
generic name: ZINC OXIDE
Sunceutical SPF 50 Mineral Face CreamZINC OXIDEBaxter Laboratories Pty. Ltd.2c408728-a1de-d51e-e063-6294a90ade0b2026-08-31WarningsName fallback
generic name: ZINC OXIDE
ISNTREE HYALURONIC ACID NATURAL SUNCREAMZINC OXIDEISNTREE Inc.5a3a59b2-18b6-521b-e063-6294a90a29582026-08-29WarningsName fallback
generic name: ZINC OXIDE
Utu Broad Spectrum SPF 30 Moisturizing Body SunscreenZINC OXIDEUtu Co59938ace-c97c-d758-e063-6394a90a77e42026-08-28WarningsName fallback
generic name: ZINC OXIDE
Utu Broad Spectrum SPF 30 Moisturizing Face Mineral Zinc Oxide Sunscreen UnscentedZINC OXIDEUtu Co5982e790-7cdb-c96c-e063-6394a90a02d42026-08-28WarningsName fallback
generic name: ZINC OXIDE
Utu Hydrating Sun Balm Broad Spectrum SPF 50ZINC OXIDEUtu Co59d1d0ac-2444-d6f9-e063-6294a90ae80c2026-08-28WarningsName fallback
generic name: ZINC OXIDE
Hello Bello Mineral Sunscreen SPF 50ZINC OXIDETopiderm, Inc.54f12764-5c37-4a05-bf96-209fedb93fd12026-08-28WarningsName fallback
generic name: ZINC OXIDE
Hero Force Shield Superlight Sunscreen SPF 30ZINC OXIDEChurch & Dwight Co., Inc.140268a9-adb9-4574-ad82-4a2e924dc8082026-08-26WarningsName fallback
generic name: ZINC OXIDE
MUSTELA Diaper Rash 1 2 3ZINC OXIDEExpanscience Laboratories d/b/a Mustela59cf1d1e-e951-9d58-e063-6394a90af0f32026-08-24WarningsName fallback
generic name: ZINC OXIDE
MUSTELA Diaper Rash 1 2 3ZINC OXIDEExpanscience Laboratories d/b/a Mustela163f388e-849d-4b7e-93c1-9045d77a9ec22026-08-21WarningsName fallback
generic name: ZINC OXIDE
ClaraVieZINC OXIDEGentell LLC596abd98-17d7-2a22-e063-6294a90af57d2026-08-19WarningsName fallback
generic name: ZINC OXIDE
Utu Broad Spectrum SPF 50 Tinted Sunscreen-StickZINC OXIDEUtu Co596e17d3-3064-1cda-e063-6294a90af9632026-08-19WarningsName fallback
generic name: ZINC OXIDE
MedprideZINC OXIDEShield Line LLCe2689cae-e347-4c0b-825b-6281a0b7c2f12026-08-18WarningsName fallback
generic name: ZINC OXIDE
Zinc OxideZINC OXIDEADUSA Distribution, LLC5940399c-31e3-6d51-e063-6294a90a8e7c2026-08-17Warnings, Adverse reactionsName fallback
generic name: ZINC OXIDE
Sun Zapper - Acne Pure Zinc Sunscreen SPF50ZINC OXIDEVeganic SKN Limited3ee435a5-70fb-0c8a-e063-6394a90a650a2026-08-16WarningsName fallback
generic name: ZINC OXIDE
ISNTREE HYALURONIC ACID SENSITIVE SUNSCREENZINC OXIDEISNTREE Inc.58e38665-0bca-fb02-e063-6394a90ad62a2026-08-13WarningsName fallback
generic name: ZINC OXIDE
TENA Proskin protective creamZINC OXIDEEssity HMS North America Inc.b840377f-a297-4aff-900e-7ea8b7c987172026-08-13Warnings, Adverse reactionsName fallback
generic name: ZINC OXIDE
Elta MD Skincare UV Stick Broad Spectrum SPF50ZINC OXIDECP Skin Health Group, Inc58dd81db-46d4-d763-e063-6394a90abb0b2026-08-12WarningsName fallback
generic name: ZINC OXIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.