Unnaplast® with Calamine

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]

UNNAPLAST WITH CALAMINE- zinc oxide, calamine dressing 
Pharmaplast SAE

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.

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Unnaplast® with Calamine

Drug Facts

Active ingredient:

Zinc Oxide 10% Calamine 0.50%

Purpose:

Skin Protectant

Uses:

Unnaplast® used in the treatment of Venous stasis ulcers, some selected eczematous eruptions, lymphatic edema, thrombophlebitis, minor fractures, sports injuries, sprains and strains and burns.

Warnings:

Reuse of the product increases risk of infection.
Dispose carefully in a manner preventing cross-contamination.
For external use only.
Do not make reverse turns while wrapping Unnaplast® bandage.
Do not use if you are hypersensitive to the product or any of its components.
Do not use on grossly macerated skin.
If condition worsens or does not improve within 7 days, consult a doctor.
Avoid contact with eyes.

Keep out of reach of children.

Directions:

1. Position the patient’s leg in a slightly flexed position.
2. Apply Unnaplast® in a circular motion from the foot to the knee. The wrap should be snug but not tight. To cover the area completely, be sure each turn overlaps the previous one by half the bandage’s width.
3. Continue wrapping the patient’s leg up to the knee, using firm even pressure. Mold the boot with your free hand as you apply the bandage to make it smooth.
4. Apply an elastic or cohesive bandage to secure dressing and maintain compression.

Inactive ingredients:

Carboxymethylcellulose
Glycerol
Purified water

Open weave cotton bandage with zinc oxide paste.

Pharmaplast

Made of open weave, light weight, finished selvage edges, cotton bandage impregnated with creamy zinc oxide paste with calamine.

Pharmaplast S.A.E.

Amria, free zone 23512,
Alexandria, Egypt
www.pharmaplast-online.com

Packaging

UNNAPLAST WITH CALAMINE 
zinc oxide, calamine dressing

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 28691-1005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	3 mg  in 1 cm2
FERRIC OXIDE RED (UNII: 1K09F3G675) (FERRIC OXIDE RED - UNII:1K09F3G675)	FERRIC OXIDE RED	0.15 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: 28691-1005-1	1 in 1 BOX	02/17/2021	04/14/2023
1		6855 cm2 in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 28691-1005-2	1 in 1 BOX	02/17/2021	04/14/2023
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	02/17/2021	04/14/2023

Labeler - Pharmaplast SAE (644773319)

Establishment
Name	Address	ID/FEI	Business Operations
Pharmaplast SAE		644773319	manufacture(28691-1005)

Revised: 4/2023

Document Id: 1517fa8f-811e-4199-99fa-acce0f58d087

34390-5

Set id: a14480ef-a816-4d13-b919-d33cc8a84b44

Version: 2

Effective Time: 20230414