DYNASHIELD WITH DIMETHICONE - zinc oxide and dimethicone cream 
Dynarex Corporation

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Dynashield Zinc Oxide / Dimethicone

Active ingredient        Purpose           
Zinc Oxide (200 mg)      Diaper Rash
Dimethicone 1.8%         Skin Protectant

Uses:

• Helps treat and prevent diaper rash.
• Dries the oozing and weeping of
• poison ivy
  
• poison oak
  
• poison sumac
  
  

Warnings:

For external use only

When using this product

• do not get into eyes
  

Stop use and ask a doctor if

• conditions worsens
• symptoms last more than 7 days or clear up and occur again in a few days, consult a physician
• over large areas of the body
• if you are allergic to any of these ingredients

Do not use on

• deep or puncture wounds
• animal bites
• serious burns

Keep out of reach of children

if swallowed, get medical help or contact a Poison Control Center right away

Directions:

For diaper rash

• change wet and soiled diapers promptly
• cleanse the diaper area and allow to dry
• Apply ointment liberally with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged

For poison ivy, oak and sumac

• apply ointment liberally as often as needed

Other information

• Do not use if seal is punctured or not visible
• store at room temperature 15°-30° C (59°-86° F)
• avoid excessive heat

"Contains color additives including FD&C Yellow No. 5 (tartrazine)".

Inactive ingredients

Aloe Barbadensis Leaf Juice, Cetyl Alcohol, Cholecaliferol, Diazolidinyl Urea, Fragrance, Lanolin, Methylparaben, Mineral Oil, Petrolatum, Purified Water, Retinyl Palmitate, Sodium Borate, Stearic Acid, Tocopheryl Acetate, Yellow 5, Yellow 6, Zea Mays (Corn) oil

Principal Display Panel

DynaShield with Dimethicone:

DYNASHIELD  WITH DIMETHICONE zinc oxide and dimethicone   cream

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 67777-228 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 200 mg  in 100 g DIMETHICONE (DIMETHICONE) DIMETHICONE 1.8 g  in 100 g

Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF 1 g  in 100 g CETYL ALCOHOL 5 g  in 100 g CHOLECALCIFEROL 0.01 g  in 100 g DIAZOLIDINYLUREA 0.1 g  in 100 g LANOLIN 2.0 g  in 100 g METHYLPARABEN 0.1 g  in 100 g MINERAL OIL 28 g  in 100 g PETROLATUM 6.75 g  in 100 g VITAMIN A PALMITATE 001 g  in 100 g SODIUM BORATE 0.1 g  in 100 g STEARIC ACID 4.5 g  in 100 g .ALPHA.-TOCOPHEROL ACETATE, D- 0.5 g  in 100 g CORN OIL 1.0 g  in 100 g WATER   FD&C YELLOW NO. 5

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 67777-228-01 24 TUBE In 1 CARTON contains a TUBE 1 113.4 g In 1 TUBE This package is contained within the CARTON (67777-228-01)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	09/01/2009

Labeler - Dynarex Corporation (008124539)

Registrant - Dynarex Corporation (008124539)

Establishment
Name	Address	ID/FEI	Operations
Choice Laboratories		650070394	manufacture

Revised: 12/2009Dynarex Corporation