UNNAPLAST WITH CALAMINE- zinc oxide and calamine paste

UNNAPLAST with CALAMINE by

Drug Labeling and Warnings

UNNAPLAST with CALAMINE by is a Otc medication manufactured, distributed, or labeled by Pharmaplast SAE. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug facts:

Active Ingredients

Zinc Oxide 25%
Calamine 1%

Purpose

Skin Protectant

Uses

• Dries the oozing and weeping of poison ivy, poison oak, or poison sumac.
  
• Ideal for managing extremities (e.g., varicose ulcers) requiring protection and support.

Warning

• For external use only
  
• If condition worsens or does not improve within 7 days, consult a doctor.
  
• Avoid contact with eyes.

Keep Out of Reach of Children Section

Keep this and all medicines out of children's reach.

Inactive Ingredients:

• Carboxy methyl cellulose
  
• Glycerol
  
• Purified water

Directions

1. Begin bandaging at base of toes, without pressure, keeping foot and leg at right angle. Continue bandaging beyond ankle, doubling back to ensure molding to contours of leg
   
2. Continue bandaging to just below the knees.
   
3. Apply an elastic adhesive bandage.

PRINCIPAL DISPLAY PANEL

Unnaplast™
Compression Plus occlusion
result in increased healing rate.
7.5 cm x 9.14 mts
10 cm x 9.14 mts

INGREDIENTS AND APPEARANCE

UNNAPLAST WITH CALAMINE 
zinc oxide and calamine paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 28691-2501
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	5 mg  in 1 cm2
FERRIC OXIDE RED (UNII: 1K09F3G675) (FERRIC OXIDE RED - UNII:1K09F3G675)	FERRIC OXIDE RED	0.2 mg  in 1 cm2

Inactive Ingredients
Ingredient Name	Strength
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 28691-2501-1	1 in 1 BOX	01/01/2014
1		6855 cm2 in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 28691-2501-2	1 in 1 BOX	01/01/2014
2		9140 cm2 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part347	01/01/2014

Labeler - Pharmaplast SAE (557735337)

Establishment
Name	Address	ID/FEI	Business Operations
Pharmaplast SAE		557735337	MANUFACTURE(28691-2501)