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

  • 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 AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O) Dimethicone10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58466-013-1388 mL in 1 BOTTLE; Type 0: Not a Combination Product11/01/201212/01/2017
2NDC:58466-013-18236 mL in 1 BOTTLE; Type 0: Not a Combination Product11/01/201212/01/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34711/01/201212/01/2017
Labeler - Dermazone Solutions, Inc. (136116865)

Revised: 1/2018
Document Id: 0fd8a63d-6581-4fea-8681-276ee55a7ec3
Set id: 9f12031e-2082-48fe-abda-e90609ce89ba
Version: 2
Effective Time: 20180102
 
Dermazone Solutions, Inc.