NORML SHIELD- dimethicone cream 
MPM Medical LLC

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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MP00022 MPM Normlshield Skin Protectant 4 oz (update DUNS)

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

MP00022 Artwork MPM Normlshield Skin Protectant 4 oz

NORML SHIELD 
dimethicone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66977-022
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE45 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
WATER (UNII: 059QF0KO0R)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
GLYCOL STEARATE (UNII: 0324G66D0E)  
IMIDUREA (UNII: M629807ATL)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
MINERAL OIL (UNII: T5L8T28FGP)  
PEG-40 CASTOR OIL (UNII: 4ERD2076EF)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66977-022-04113 g in 1 TUBE; Type 0: Not a Combination Product02/01/1993
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35602/01/1993
Labeler - MPM Medical LLC (081241522)

Revised: 3/2022
Document Id: d9e43558-8e66-ede5-e053-2995a90a0ad8
Set id: a1b74662-f545-41a0-9969-64d237585b2d
Version: 4
Effective Time: 20220310
 
MPM Medical LLC