Claravie - Gentell LLC

Manufacturer
Gentell LLC
Effective date
2026-08-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-08-26 01:01:39

Label at a glance#

ProductClaravie
Active ingredientDIMETHICONE
Label structure14 sections

Indications and uses

Temporarily protects and helps relieve chafed, chapped or cracked skin. Helps protect from the drying effects of wind and cold weather. Helps prevent and undergarment rash. Protects minor skin irritation associated with undergarment rash and helps seal out wetness.

Dosage and administration

As a skin protectant: Apply as needed As an undergarment cream: Change wet and soiled undergarment promptly, because the undergarment area and allow to dry. Apply cream liberally as often as necessary with each undergarment change, especially at bedtime or anytime when exposure to wet undergarment may be prolonged.

Storage and handling

Store between 59°F-86°F (15°C-30°C)

Label contents#

Full prescribing information#

DESCRIPTION SECTION

Powered by nature, perfected by science—the ClaraVie™ skin care collection offers a harmonious blend of advanced technology and natural ingredients for radiant, healthy skin.

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Dimethicone 5% w/w

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

  • Temporarily protects and helps relieve chafed, chapped or cracked skin.
  • Helps protect from the drying effects of wind and cold weather.
  • Helps prevent and undergarment rash.
  • Protects minor skin irritation associated with undergarment rash and helps seal out wetness.

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

do not get in eyes.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • Condition worsens
  • Symptoms last more than 7 days or clear 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, contact a physician or Poison Control Center.

Directions

INSTRUCTIONS FOR USE SECTION

As a skin protectant: Apply as needed

As an undergarment cream:

  • Change wet and soiled undergarment promptly, because the undergarment area and allow to dry.
  • Apply cream liberally as often as necessary with each undergarment change, especially at bedtime or anytime when exposure to wet undergarment may be prolonged.

Other Information

STORAGE AND HANDLING SECTION

  • Store between 59°F-86°F (15°C-30°C)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Glyceryl Monostearate, Stearic Acid, PEG-100 Monostearate, Cetostearyl Alcohol, Glycerin, Propylene Glycol, Niacinamide, Phenoxyethanol, Aloe Vera Leaf, Zea Mays Oil, Fragrance, Carbomer, Trolamine, EDTA Disodium, Orange Oil, Canola Oil, Citrus Medica Limonum (Lemon) Peel Oil, Lavender Oil, Olive Oil, Alpha Tocopherol Acetate, Ascorbyl Palmitate, Pyridoxine HCl, Vitamin A Palmitate, Cholecalciferol, Ethylhexylglycerin

DOSAGE & ADMINISTRATION SECTION

  • Apply cream liberally as often as necessary with each undergarment change, especially at bedtime or anytime when exposure to wet undergarment may be prolonged.

Dimethicone Skin Protectant

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dimethicone Skin Protectant Label:

Dimethicone ProtectantDimethicone Protectant

Products#

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

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61554-31361554-313-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 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
ClaravieDIMETHICONEGentell LLC59c6da39-b5f1-8253-e063-6394a90a0e8f2026-08-24WarningsExact identifier
ndc (package): 61554-313-11
ndc (product): 61554-313
ndc11 (package): 61554031311
spl id: 59c6da39-b5f2-8253-e063-6394a90a0e8f
spl set id: 59c6da39-b5f1-8253-e063-6394a90a0e8f

Reported adverse events (FAERS/openFDA)#

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