Cure-Aid POVI

Drug Labeling and Warnings

Drug Details [pdf]

CURE-AID POVI ADHESIVE BANDAGE- povidone iodine patch 
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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Cure-Aid POVI

ACTIVE INGREDIENT

Povidone Iodine USP 10% (equivalent to 1% titratable iodine)

PURPOSE

Antiseptic

USE

First Aid Antiseptic to help prevent infection in minor cuts, scrapes and burns

WARNINGS

For external use only.

Do not use

• in the eyes or over large areas of the body
  
• longer than 1 week unless directed by a doctor

Stop use and ask a doctor

• if condition persists or gets worse
  
• in case of deep puncture wounds, animal bites or serious burns

Keep out of reach of children

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

DIRECTIONS

Clean the affected area. Apply one adhesive bandage 1-3 times daily.

OTHER INFORMATION

Store at room temperature 15° - 30° C (59° - 86° F)

INACTIVE INGREDIENTS

Purified water, PEG-400, PEG-4000, viscose fabric

Packaging

CURE-AID POVI ADHESIVE BANDAGE 
povidone iodine patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 28691-1000
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	100 mg

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 28691-1000-2	20 in 1 BOX; Type 0: Not a Combination Product	01/01/2014	08/07/2019
2	NDC: 28691-1000-3	30 in 1 BOX; Type 0: Not a Combination Product	01/01/2014	08/07/2019
3	NDC: 28691-1000-4	40 in 1 BOX; Type 0: Not a Combination Product	01/01/2014	08/07/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part333C	01/01/2014	08/07/2019

Labeler - Pharmaplast SAE (557735337)

Establishment
Name	Address	ID/FEI	Business Operations
Pharmaplast SAE		557735337	MANUFACTURE(28691-1000)

Revised: 8/2019

Document Id: bcb7feb5-d246-414e-91da-676ac924cf03

34390-5

Set id: ce83cf49-844f-48aa-9ec4-b83666ec8598

Version: 4

Effective Time: 20190807