FDA.reportPublic FDA data

Naturasil MollusCalm

Manufacturer
Nature's Innovation, Inc.
Effective date
2023-08-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:27:03

Label at a glance#

ProductNaturasil MollusCalm
Active ingredientTHUJA OCCIDENTALIS LEAF
Label structure9 sections

Indications and uses

Symptomatic treatment of Water Warts and Itching Bumps.

Dosage and administration

Thoroughly wash and dry area. Apply 3-4 times daily to affected area. Bumps will diminish and flake away over 2-6 weeks depending on severity of condition. Some individuals may be sensitive to essential oils. Skin test for tolerability. If irritation or reaction occurs, discontinue use.

Label contents#

Full prescribing information#

Active Ingredients:

OTC - ACTIVE INGREDIENT SECTION

Thuja Occidentalis 6X HPUS

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

Purpose

OTC - PURPOSE SECTION

Water Wart and Itching Bump Relief

Uses:

INDICATIONS & USAGE SECTION

Symptomatic treatment of Water Warts and Itching Bumps.

Warnings:

WARNINGS SECTION

For external use only. Ask a doctor before use if pregnant or nursing. Avoid using near eyes or mouth.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. Do not use if tamper evident seal is broken. In case of ingestion call Poison Control Center hotline immediately at 1-800-222-1222.

Directions:

DOSAGE & ADMINISTRATION SECTION

Thoroughly wash and dry area. Apply 3-4 times daily to affected area. Bumps will diminish and flake away over 2-6 weeks depending on severity of condition. Some individuals may be sensitive to essential oils. Skin test for tolerability. If irritation or reaction occurs, discontinue use.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Cedar Leaf Oil, Melaleuca Alternifolia Leaf Oil, Pale Pressed Ricinus Communis Seed Oil.

Questions? Comments?

OTC - QUESTIONS SECTION

www.naturasil.com

866-371-2499

Mfd. by: Nature's Innovation, Inc. 5317 Palmero Ct., Buford, GA 30518

SPL UNCLASSIFIED SECTION

Homeopathic Formula

All Natural Plant Extracts

Not tested on animals.
NM15L Rev 081723

*These statements or claims are based upon traditional homeopathic practice. They have not been reviewed by the Food & Drug Administration. "X" is a homeopathic dilution.
For more details, see: www.naturasil.com/pages/what-is-homeopathy

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

liquid 15 mLliquid 15 mL

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10893-81010893-810-15

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
THUJA OCCIDENTALIS LEAF0T0DQN8786ACTIB
CEDAR LEAF OILBJ169U4NLGIACT
MELALEUCA ALTERNIFOLIA LEAFG43C57162KIACT
CASTOR OILD5340Y2I9GIACT

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
3ace446c-8d32-4dd8-bbbe-58546c615a4227117ba3-1606-4afd-90ff-df945ed425792024-06-06WarningsExact identifier
spl set id: 27117ba3-1606-4afd-90ff-df945ed42579

Reported adverse events (FAERS/openFDA)#

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