Label: POVIDONE-IODINE PREP PAD- povidone-iodine swab
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Contains inactivated NDC Code(s)
NDC Code(s): 71584-0104-1 - Packager: Guangdong Comfort Medical Products Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated December 5, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- CAUTION: Keep out of reach of children
- Indications and usage section
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WARNINGS
For external use only. Flammable, keep away from fire or flame.
Do notuse
﹒in the eyes or apply over large areas of the body.
﹒on individuals who are allergic or sensitive to iodine.
Stop use
If irritation, redness or other symptoms develop.
Ask a doctor
If condition persists or gets worse or in case of deep or puncture wounds, animal bites, serious burns.
- Directions
- INACTIVE INGREDIENT
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DRUG FACTS
Active ingredient
Povidone Iodine USP, 10% w/v
(equivalent to 1% titratable iodine)
Purpose
Antiseptic
Use
First aid to help prevent infection in minor cuts, scrapes, and burns
Warnings
For external use only. Flammable, keep away from fire or flame.
Do notuse
﹒in the eyes or apply over large areas of the body.
﹒on individuals who are allergic or sensitive to iodine.
Stop use
If irritation, redness or other symptoms develop.
Ask a doctor
If condition persists or gets worse or in case of deep or puncture wounds, animal bites, serious burns.
CAUTION: Keep out of reach of children.
If swallowed, get medical help or contact Poison Control Center right away.
Directions
Apply product on the area 1-3 times daily and discard.
Other information: Store at room temperature.
Inactive ingredients
ctric acid, glycerin, Nonoxynol-10, purified water, sodium hydroxide
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INGREDIENTS AND APPEARANCE
POVIDONE-IODINE PREP PAD
povidone-iodine swabProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71584-0104 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE 9.43 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) SODIUM HYDROXIDE (UNII: 55X04QC32I) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71584-0104-1 9.43 g in 1 POUCH; Type 0: Not a Combination Product 07/17/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 07/17/2017 Labeler - Guangdong Comfort Medical Products Co., Ltd. (544507534) Registrant - Guangdong Comfort Medical Products Co., Ltd. (544507534)