DYNASHIELD

Main information

  • Trade name:
  • DYNASHIELD- zinc oxide ointment
  • Composition:
  • ZINC OXIDE 1.8 g in 100 g
  • Administration route:
  • TOPICAL
  • Prescription type:
  • OTC DRUG
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • DYNASHIELD- zinc oxide ointment
    United States
  • Language:
  • English

Therapeutic information

  • Therapeutic indications:
  • ​Skin Protectant - Helps treat and prevent diaper rash - Temporarily protects minor • cuts • scrapes • burns - Dries the oozing and weeping of poison • ivy • oak • sumac

Status

  • Source:
  • DailyMed - NLM - National Library of Medicine
  • Authorization status:
  • OTC monograph final
  • Authorization number:
  • 67777-407-01, 67777-407-02, 67777-407-03, 67777-407-04
  • Last update:
  • 03-06-2019

Summary of Product characteristics: dosage, interactions, side effects

DYNASHIELD- zinc oxide ointment

Dynarex Corporation

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.

----------

1195, 1196

Active Ingredient

Zinc Oxide 1.8%

Purpos e

Skin Protectant

Us es

Helps treat and prevent diaper rash

Temporarily protects minor cuts scrapes burns

Dries the oozing and weeping of poison ivy oak sumac

Warnings

For External Use Only

When using this product

Do not get in 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

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 as often as necessary, with each diaper change, especially at bedtime or

anytime when exposure to wet diapers may be prolonged.

For other uses: Apply as needed.

Other Information

Store at room temperature

Avoid excessive heat

Inactive Ingredients

Glycerin USP, Cetostearyl Alcohol USP, Cetyl Alcohol USP, White Petrolatum USP (white soft

paraffin), Mineral Oil USP, Anhyudrous Lanolin USP, Cetomacrogol 1000 BP, Aloe vera Extract,

Methyl Paraben USP, Propyl Paraben USP, Perfume Lavander K748, Alpha Tocopherol USP,

Trolamine USP (Triethanolamine), Vitamin A USP, Cholecalciferol (Vitamin D3) USP, FD&C Yellow

No. 5 (tartrazine)

Labeling

DYNASHIELD

zinc oxide ointment

Dynarex Corporation

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 7777-40 7

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ZINC O XIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)

ZINC OXIDE

1.8 g in 10 0 g

Inactive Ingredients

Ingredient Name

Stre ng th

ALPHA-TO CO PHERO L (UNII: H4N8 55PNZ1)

ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)

PETRO LATUM (UNII: 4T6 H12BN9 U)

TRO LAMINE (UNII: 9 O3K9 3S3TK)

WATER (UNII: 0 59 QF0 KO0 R)

LANO LIN (UNII: 7EV6 5EAW6 H)

CETETH-2 0 (UNII: I8 35H2IHHX)

MINERAL O IL (UNII: T5L8 T28 FGP)

METHYLPARABEN (UNII: A2I8 C7HI9 T)

PRO PYLPARABEN (UNII: Z8 IX2SC1OH)

GLYCERIN (UNII: PDC6 A3C0 OX)

CETYL ALCO HO L (UNII: 9 36 JST6 JCN)

CETO STEARYL ALCO HO L (UNII: 2DMT128 M1S)

CHO LECALCIFERO L (UNII: 1C6 V77QF41)

VITAMIN A (UNII: 8 1G40 H8 B0 T)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 7777-40 7-0 1

5 g in 1 PACKET; Type 0 : No t a Co mbinatio n Pro duct

0 5/23/20 18

2

NDC:6 7777-40 7-0 2

15 g in 1 PACKET; Type 0 : No t a Co mbinatio n Pro duct

0 5/23/20 18

3

NDC:6 7777-40 7-0 3

114 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

0 5/23/20 18

4

NDC:6 7777-40 7-0 4

427.5 g in 1 JAR; Type 0 : No t a Co mbinatio n Pro duct

0 5/23/20 18

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt347

10 /0 1/20 14

Labeler -

Dynarex Corporation (008124539)

Registrant -

Dynarex Corporation (008124539)

Revised: 2/2019