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NDC 66977-0022-04 Norml Shield 45 mg/g Details

Norml Shield 45 mg/g

Norml Shield is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by MPM Medical LLC. The primary component is DIMETHICONE.

Product Information

NDC	66977-0022
Product ID	66977-022_d9e43558-8e66-ede5-e053-2995a90a0ad8
Associated GPIs	90972030003718
GCN Sequence Number	051859
GCN Sequence Number Description	dimethicone CREAM (G) 4.5 % TOPICAL
HIC3	L3A
HIC3 Description	PROTECTIVES
GCN	19256
HICL Sequence Number	004794
HICL Sequence Number Description	DIMETHICONE
Brand/Generic	Brand
Proprietary Name	Norml Shield
Proprietary Name Suffix	n/a
Non-Proprietary Name	dimethicone
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	45
Active Ingredient Units	mg/g
Substance Name	DIMETHICONE
Labeler Name	MPM Medical LLC
Pharmaceutical Class	Skin Barrier Activity [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part356
Listing Certified Through	2023-12-31

Package

Package Images

NDC 66977-0022-04 (66977002204)

Pricing Information	N/A
NDC Package Code	66977-022-04
Billing NDC	66977002204
Package	113 g in 1 TUBE (66977-022-04)
Marketing Start Date	1993-02-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL a1b74662-f545-41a0-9969-64d237585b2d Details

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

INGREDIENTS AND APPEARANCE

NORML SHIELD

dimethicone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:66977-022
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	45 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:66977-022-04	113 g in 1 TUBE; Type 0: Not a Combination Product	02/01/1993

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part356	02/01/1993

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