Your browser does not support JavaScript! NANOCARE (DIMETHICONE) CREAM [DERAMZONE SOLUTIONS, INC.]
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RxNorm Names

NANOCARE (dimethicone) cream
[Deramzone Solutions, Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE:MOST OTC DRUGS ARE NOT REVIEWED AND APPROVED BY FDA, HOWEVER THEY MAY BE MARKETED IF THEY COMPLY WITH APPLICABLE REGULATIONS AND POLICIES. FDA HAS NOT EVALUATED WHETHER THIS PRODUCT COMPLIES.
Drug Label Sections

Drug Facts

Active ingredients

Dimethicone 1.0%

Purpose

Skin protectant

Uses

  • helps prevent and relieve chafed or cracked skin

Warnings

For external use only.

When using this product keep out of eyes.

Do not use on

  • deep wounds
  • animal bites
  • serious burns

Stop use and ask a doctor if

  • condition worsens
  • symptoms lasts more than seven days or clear up and occur again within a few days

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • apply to dry areas as needed
  • children under 6 months: Ask a doctor

Inactive ingredients

USP water, mineral oil, petrolatum, alcohol, glyceryl stearate, PEG-100 stearate, paraffin, cetyl alcohol, lecithin, essential oils, imidazolidinyl urea, methylparaben, propylparaben, triethanolamine

Manufactured by:
Dermazone Solutions, Inc.
2440 30th Avenue North St. Petersburg, FL 33713 USA

Distributed by: Universal Sales & Marketing, Inc.

PRINCIPAL DISPLAY PANEL - 118 mL Jar Label

nanocare
for skin

Penetrating
Moisturizing Cream
with sealing barrier

4.0 FL OZ (118 mL)

PRINCIPAL DISPLAY PANEL - 118 mL Jar Label
NANOCARE 
dimethicone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58466-024
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dimethicone (Dimethicone) Dimethicone10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
water 
mineral oil 
petrolatum 
alcohol 
glyceryl monostearate 
PEG-100 stearate 
paraffin 
cetyl alcohol 
imidurea 
methylparaben 
propylparaben 
trolamine 
Packaging
#Item CodePackage Description
1NDC:58466-024-24118 mL in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart33210/15/2012
Labeler - Deramzone Solutions, Inc. (136116865)
Establishment
NameAddressID/FEIBusiness Operations
Deramzone Solutions, Inc.136116865MANUFACTURE(58466-024)

Revised: 10/2012
Document Id: 0f895e98-07ff-42c9-9e2a-17f6e328dae5
Set id: 064b0238-ea0b-4c3b-a032-863be27205ad
Version: 1
Effective Time: 20121018
 
Deramzone Solutions, Inc.

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