POVIDONE-IODINE PAD- POVIDONE-IODINE SWAB (povidone iodine 10% w/w- equivalent to iodine 1% swab

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)

Available from:

Raya Pharmaceuticals LLC

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Antiseptic for preparation of the skin. For external use only. Apply locally as needed. POVIDONE-IODINE 10% W/W(equivelent to iodine 1%)................. Purpose: Antiseptic

Authorization status:

OTC monograph final

Summary of Product characteristics

POVIDONE-IODINE PAD- POVIDONE-IODINE SWAB- POVIDONE IODINE 10% W/W
(EQUIVALENT TO IODINE 1%) SWAB
RAYA PHARMACEUTICALS LLC
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POVIDONE-IODINE PAD
10% POVIDONE-IODINE
Antiseptic for preparation of the skin.
For external use only.
Apply locally as needed.
For external use only.
For external use only.
Discontinue use if irritation and redness develop.
Keep out of reach of children.
Store at room temperature
Apply Localy As Needed
For External Use Only
Discontinue use if Irretation and reddness appear
Keep Out of Reach of Children
Water is added as inactive ingredient
POVIDONE-IODINE 10% W/W(equivelent to iodine 1%)
POVIDONE-IODINE 10% W/W(equivelent to iodine 1%).................
Purpose: Antiseptic
Keep Out of reach of Children
NDC:82098-0617-10
POVIDONE-IODINE PAD
10% POVIDONE-IODINE
Single USE Only
POVIDONE-IODINE PAD- POVIDONE-IODINE SWAB
povidone iodine 10% w/w (equivalent to iodine 1%) swab
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:82098-617
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)
IODINE
10 g in 100 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
WATER (UNII: 059QF0KO0R)
PRODUCT CHARACTERISTICS
COLOR
red
SCORE
SHAPE
SIZE
FLAVOR
IMPRINT CODE
CONTAINS
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
MARKETING END
Raya Pharmaceuticals LLC
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:82098-617-
10
0.6 g in 1 POUCH; Type 0: Not a Combination
Product
04/03/2022
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
OTC Monograph Drug
M003
04/03/2022
LABELER -
Raya Pharmaceuticals LLC (106631637)
Revised: 10/2023