NANOCARE- dimethicone lotion 
Dermazone 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

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, 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 Type HUMAN OTC DRUG Item Code (Source) NDC:58466-013
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)  
polysorbate 60 (UNII: CAL22UVI4M)  
diethanolamine cetyl phosphate (UNII: 4UG0316V9S)  
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:58466-013-13 88 mL in 1 BOTTLE
2 NDC:58466-013-18 236 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part332 11/01/2012
Labeler - Dermazone Solutions, Inc. (136116865)
Establishment
Name Address ID/FEI Business Operations
Dermazone Solutions, Inc. 136116865 MANUFACTURE(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.