NANOCARE- dimethicone cream 
Deramzone Solutions, Inc.

Disclaimer: 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.

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nanocare for skin
Penetrating Moisturizing Cream

Drug Facts

Active ingredients

Dimethicone 1.0%

Purpose

Skin protectant

Uses

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

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 Type HUMAN OTC DRUG Item Code (Source) NDC:58466-024
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O) Dimethicone 10 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
water (UNII: 059QF0KO0R)  
mineral oil (UNII: T5L8T28FGP)  
petrolatum (UNII: 4T6H12BN9U)  
alcohol (UNII: 3K9958V90M)  
glyceryl monostearate (UNII: 230OU9XXE4)  
PEG-100 stearate (UNII: YD01N1999R)  
paraffin (UNII: I9O0E3H2ZE)  
cetyl alcohol (UNII: 936JST6JCN)  
imidurea (UNII: M629807ATL)  
methylparaben (UNII: A2I8C7HI9T)  
propylparaben (UNII: Z8IX2SC1OH)  
trolamine (UNII: 9O3K93S3TK)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:58466-024-24 118 mL in 1 JAR
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part332 10/15/2012
Labeler - Deramzone Solutions, Inc. (136116865)
Establishment
Name Address ID/FEI Business Operations
Deramzone Solutions, Inc. 136116865 MANUFACTURE(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.