FDA.reportPublic FDA data

Scabies Topical Cream Label

Manufacturer
Nature's Innovation, Inc.
Effective date
2021-01-14
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 02:14:09

Label at a glance#

ProductNaturasil Scabies
Active ingredientSULFUR
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Drug Facts

Active Ingredients:   Sulfur 1X HPUS

DESCRIPTION SECTION

The letters HPUS indicate the component(s) in this product is (are) officially monographed in the Homeopathic Pharmacopeia of the United States.

OTC - PURPOSE SECTION

Purpose: Scabies Symptom Relief

INDICATIONS & USAGE SECTION

Uses:  Symptomatic treatment of scabies

WARNINGS SECTION

Warnings:  For external use only.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if pregnant or nursing.

OTHER SAFETY INFORMATION

Avoid using near eyes, mouth or mucous membranes. If eye contact occurs, rinse thoroughly with water and consult a doctor.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OTC - DO NOT USE SECTION

Do not use if tamper evident seal is broken.

OTHER SAFETY INFORMATION

In case of ingestion call Poison Control Center hotline immediately at 1-800-222-1222.

DOSAGE & ADMINISTRATION SECTION

Directions:  Cleanse skin thoroughly before applying. Cover the affected area with cream one time per day. If excessive drying of the skin or rash occurs, reduce the application of product or discontinue use. To speed relief, we recommend to use Naturasil Sulfur Lavender Soap. Some individuals may be senstive to sulfur or essential oils. Skin test for tolerability. If irritation or reaction occurs, discontinue use.

INACTIVE INGREDIENT SECTION

Inactive Ingredients:  Butyrospermum Parkii (Shea Butter) Fruit, Calendula (Calendula Officinalis) Oil, Cetyl Alcohol, Cetyl Palmitate, Dimethicone, Ethylhexylglycerin, Glycerine, Glyceryl Stearate, Glycine Soja (Soybean) Oil, Melaleuca Alternifolia Leaf, Polysorbate 60, Phenoxyethanol, Purified Water (Aqua), Simmondsia Chinensis (Jojoba) Seed Oil, Stearic Acid. 

OTC - QUESTIONS SECTION

Questions? Comments? www.naturasil.com 1-866-371-2499 Mfd. by:  Nature's Innovation, Inc. 2723 Brickton North Dr., Buford, GA 30518

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC# 10893-420-_

100% Natural

Plant Extracts

Naturasil

__ml

(__ fl. oz.)  Homeopathic Medicine

Scabies Topical Cream

60 mL60 mL

120 mL120 mL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10893-420-02NaturasilScabies60 mL in 1 BOTTLECREAM604
10893-420-04NaturasilScabies120 mL in 1 BOTTLECREAM1204

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10893-420NATURASIL SCABIES (SULFUR) CREAM [NATURE'S INNOVATION, INC.]4Current NDC, Legacy NDC, 2 package rows20210115_c00dfb97-a202-4a44-8f1b-e82239a863c6.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10893-42010893-420-04, 10893-420-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
SULFUR70FD1KFU70ACTIB
SHEA BUTTERK49155WL9YIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
CETYL ALCOHOL936JST6JCNIACT
CETYL PALMITATE5ZA2S6B08XIACT
DIMETHICONE92RU3N3Y1OIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
SOYBEAN OIL241ATL177AIACT
MELALEUCA ALTERNIFOLIA LEAFG43C57162KIACT
POLYSORBATE 207T1F30V5YHIACT
PHENOXYETHANOLHIE492ZZ3TIACT
WATER059QF0KO0RIACT
JOJOBA OIL724GKU717MIACT
STEARIC ACID4ELV7Z65APIACT

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
Naturasil ScabiesSULFURNature's Innovation, Inc.c00dfb97-a202-4a44-8f1b-e82239a863c62021-01-14WarningsExact identifier
ndc (package): 10893-420-02
ndc (package): 10893-420-04
ndc (product): 10893-420
ndc11 (package): 10893042002
ndc11 (package): 10893042004
spl id: 1eb2f2dc-ed15-4181-82df-056c840978a6
spl set id: c00dfb97-a202-4a44-8f1b-e82239a863c6

Reported adverse events (FAERS/openFDA)#

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