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Norml Shield

Dosage form: cream
Ingredients: DIMETHICONE 45mg in 1g
Labeler: MPM Medical, Inc.
NDC Code: 66977-022

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.

NormlShield Skin Protectant

Active Ingredient

Dimethicone 4.5%

Purpose

Skin protectant

Uses

Helps prevent and temporarily protects chafed, chapped or cracked skin

Warnings

For external use only.

Keep out of reach of children.

When using this product

do not get into eyes

Stop use and ask a doctor if
  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days

Do not use on
  • deep or puncture wounds
  • animal bites
  • serious burns

Directions

Adults and children 2 years of age and older:  Cleanse affected area.  Allow to dry. Apply MPM NormlShield® liberally. Apply as needed.

Children under 2 years of age: Consult a physician prior to use.

Other Information

Store at room temperature.

Inactive Ingredients

Aloe barbadensis leaf extract, Cetearyl alcohol and polysorbate 60, Cetyl alcohol, Deionized water, DMDM hydantoin, Glycol stearate, Imidiazolidinyl urea, Isopropyl palmitate, Methylparaben, Mineral oil, PEG-40 hydrogenated castor oil, Propylene glycol, Propylparaben, Stearic acid, Stearyl Alcohol, Tocopheryl acetate, Triethanolamine

Package Label

NORML SHIELD 
dimethicone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66977-022
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (DIMETHICONE) DIMETHICONE45 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF 
CETOSTEARYL ALCOHOL 
POLYSORBATE 60 
CETYL ALCOHOL 
WATER 
DMDM HYDANTOIN 
GLYCOL STEARATE 
IMIDUREA 
ISOPROPYL PALMITATE 
METHYLPARABEN 
MINERAL OIL 
PEG-40 CASTOR OIL 
PROPYLENE GLYCOL 
PROPYLPARABEN 
STEARIC ACID 
STEARYL ALCOHOL 
.ALPHA.-TOCOPHEROL ACETATE 
TROLAMINE 
Packaging
#Item CodePackage Description
1NDC:66977-022-04113 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35602/01/1993
Labeler - MPM Medical, Inc. (119643406)
Establishment
NameAddressID/FEIOperations
Biomed Laboratories, LLC055329696manufacture(66977-022)

Revised: 01/2013
 
MPM Medical, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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