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

IMAGE

UNNAPLAST WITH CALAMINE 
zinc oxide, calamine dressing
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 28691-1005
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION3 mg  in 1 cm2
FERRIC OXIDE RED (UNII: 1K09F3G675) (FERRIC OXIDE RED - UNII:1K09F3G675) FERRIC OXIDE RED0.15 mg  in 1 cm2
Inactive Ingredients
Ingredient NameStrength
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 28691-1005-11 in 1 BOX02/17/202104/14/2023
16855 cm2 in 1 POUCH; Type 0: Not a Combination Product
2NDC: 28691-1005-21 in 1 BOX02/17/202104/14/2023
29140 cm2 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34702/17/202104/14/2023
Labeler - Pharmaplast SAE (644773319)
Establishment
NameAddressID/FEIBusiness Operations
Pharmaplast SAE644773319manufacture(28691-1005)

Revised: 4/2023
 

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