Coral KAVI

Manufacturer
KAVI Skin Solutions, Inc.
Effective date
2020-10-20
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:32:03

Label at a glance#

ProductCoral KAVI
Active ingredientSULFUR, SALICYLIC ACID
Label structure8 sections

Indications and uses

drug facts active ingredients/purpose colloidal sulfur 2% (equivalent to precipitated sulfur 10%)…...acne treatment salicylic acid 3%.........................................acne treatment uses for the treatment and prevention of oily, acne-prone skin warnings ▪ for external use only ▪ keep out of reach of children when using this product avoid other antiseborrheics unless otherwise directed by your physician. use...

Dosage and administration

▪ use as a replacement to your existing cleanser(s) ▪ lather using warm water and cleanse affected areas ▪ rinse and pat dry ▪ cleanse once to three times per day ▪ monitor skin for dryness or irritation and reduce application as needed

Label contents#

Full prescribing information#

active ingredients, purpose

OTC - ACTIVE INGREDIENT SECTION

colloidal sulfur 2%
(equivalent to precipitated sulfur 10%)…...acne treatment
salicylic acid 3%.........................................acne treatment

Indications & Usage

INDICATIONS & USAGE SECTION

uses
for the treatment and prevention of oily, acne-prone skin

directions

▪ use as a replacement to your existing cleanser(s)
▪ lather using warm water and cleanse affected areas
▪ rinse and pat dry
▪ cleanse once to three times per day
▪ monitor skin for dryness or irritation and reduce application as needed

Dosage and Administration

DOSAGE & ADMINISTRATION SECTION

▪ use as a replacement to your existing cleanser(s)
▪ lather using warm water and cleanse affected areas
▪ rinse and pat dry
▪ cleanse once to three times per day
▪ monitor skin for dryness or irritation and reduce application as needed

Warnings

WARNINGS SECTION

▪ for external use only
▪ keep out of reach of children

when using this product avoid other antiseborrheics unless otherwise directed by your physician. use in conjunction with other oral or topical anti-acne drugs may increase dryness or irritation of the skin.

inactive ingredients

INACTIVE INGREDIENT SECTION

palm and palm kernel oil, vegetable-based moisturizer, glycerin, ethanol, water

Purpose

OTC - PURPOSE SECTION

for the treatment and prevention of oily, acne-prone skin

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

▪ for external use only
▪ keep out of reach of children

Active Ingredients, Uses, Warnings, Directions, Inactive Ingredients

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Box front and backBox front and back

drug facts

active ingredients/purpose

colloidal sulfur 2%
(equivalent to precipitated sulfur 10%)…...acne treatment
salicylic acid 3%.........................................acne treatment

uses
for the treatment and prevention of oily, acne-prone skin

warnings

▪ for external use only
▪ keep out of reach of children

when using this product avoid other antiseborrheics unless otherwise directed by your physician. use in conjunction with other oral or topical anti-acne drugs may increase dryness or irritation of the skin.

directions

▪ use as a replacement to your existing cleanser(s)
▪ lather using warm water and cleanse affected areas
▪ rinse and pat dry
▪ cleanse once to three times per day
▪ monitor skin for dryness or irritation and reduce application as needed

inactive ingredients

palm and palm kernel oil, vegetable-based moisturizer, glycerin, ethanol, water

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
312889salicylic acid 3 % / sulfur 10 % Medicated Bar SoapPSN4
312889salicylic acid 0.03 MG/MG / sulfur 0.1 MG/MG Medicated Bar SoapSCD4
312889salicylic acid 3 % / sulfur 10 % Medicated Bar SoapSY4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42771-0001-12023-01-30C16284748780-19d75b9d0-5f9b-f424-e053-dadaa90a57ceCoral KAVI
42771-0001-12020-02-28C16284748780-19d75b9d0-5f9b-f424-e053-dadaa90a57ceCoral KAVI
42771-0001-12020-01-31C16284748780-19d75b9d0-5f9b-f424-e053-dadaa90a57ceCoral KAVI

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42771-0001-1Coral KAVI1 g in 1 BOXSOAP14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42771-0001CORAL KAVI (SULFUR) SOAP [KAVI SKIN SOLUTIONS, INC.]4Legacy NDC, 1 package rows20201021_5312f8d0-9b19-69b8-e054-00144ff88e88.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
42771-000142771-0001-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
b22253a5-2988-1c71-e053-2a95a90af78a5312f8d0-9b19-69b8-e054-00144ff88e882020-10-20WarningsExact identifier
spl id: b22253a5-2988-1c71-e053-2a95a90af78a
spl set id: 5312f8d0-9b19-69b8-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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