DYNA1195- zinc oxide ointment

Dyna1195 by

Drug Labeling and Warnings

Dyna1195 by is a Otc medication manufactured, distributed, or labeled by Blossom Pharmaceuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient               Purpose

Zinc Oxide (1.8% w/w)      Skin Protectant

Purpose:

• Helps treat and prevent diaper rash
• Temporarily protects
• minor cuts
• scrapes and
• burns
• dries the oozing and weeping of
• poison ivy
• poison oak
• poison 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 in a few days, consult a physician

Keep out of reach of children.

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

Dosage and Administration:

           For skin protectant:

• Apply liberally as needed

           For diaper Rash:

• change wet and soiled diapers promptly
• allow to dry
• apply ointment liberally with each diaper change

Other information:

• Store at room temperature
• avoid excessive heat
• contains color additives including FDC yellow # 5 (Tartrazine)

INDICATIONS & USAGE

Indications: For use as a general skin protectant and diaper rash.

INACTIVE INGREDIENT

Inactive ingredients:

Aloe Vera Leaf, Alpha-Tocopherol, Ceteth-20, Cetostearyl Alcohol, Cetyl Alcohol, Cholecalciferol, Glycerin, Lanolin, Lavender perfume, Methylparaben, Mineral Oil, Petrolatum, Propylparaben, Trolamine, Vitamin A, Water

Principal Display Panel

Dyna1195 Skin Protectant

Dyna1195.jpg

INGREDIENTS AND APPEARANCE

DYNA1195 
zinc oxide ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61767-226
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	1.8 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
LANOLIN (UNII: 7EV65EAW6H)
CETETH-20 (UNII: I835H2IHHX)
MINERAL OIL (UNII: T5L8T28FGP)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
GLYCERIN (UNII: PDC6A3C0OX)
CETYL ALCOHOL (UNII: 936JST6JCN)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CHOLECALCIFEROL (UNII: 1C6V77QF41)
VITAMIN A (UNII: 81G40H8B0T)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PETROLATUM (UNII: 4T6H12BN9U)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61767-226-01	5 g in 1 PACKET
2	NDC: 61767-226-02	15 g in 1 PACKET
3	NDC: 61767-226-03	114 g in 1 TUBE
4	NDC: 61767-226-04	427.5 g in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	10/23/2014

Labeler - Blossom Pharmaceuticals (677381470)