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

NANOCARE (dimethicone) lotion
[Dermazone 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, lecithin, polysorbate 60, DEA-cetyl phosphate, carbomer, imidazolidinyl urea, methylparaben, propylparaben, triethanolamine, essential oils

Manufactured by:
Dermazone Solutions, Inc.
2440 30th Avenue North St. Petersburg, FL 33713 USA
Distributed by: Universal Sales & Marketing, Inc.

PRINCIPAL DISPLAY PANEL - 236 mL Bottle Label

nanocare
for skin

Penetrating
Moisturizing
Body Lotion

with sealing barrier

Clinical Skin Care
with Lyphazome® Technology

8.0 FL OZ (236 mL)

PRINCIPAL DISPLAY PANEL - 236 mL Bottle Label
NANOCARE 
dimethicone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58466-013
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 
polysorbate 60 
diethanolamine cetyl phosphate 
imidurea 
methylparaben 
propylparaben 
trolamine 
Packaging
#Item CodePackage Description
1NDC:58466-013-1388 mL in 1 BOTTLE
2NDC:58466-013-18236 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33211/01/2012
Labeler - Dermazone Solutions, Inc. (136116865)
Establishment
NameAddressID/FEIBusiness Operations
Dermazone Solutions, Inc.136116865MANUFACTURE(58466-013)

Revised: 10/2012
Document Id: 973252f0-e9cc-4256-abb2-50b70b35dd9e
Set id: 9f12031e-2082-48fe-abda-e90609ce89ba
Version: 1
Effective Time: 20121024
 
Dermazone Solutions, Inc.

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