Sunmark Povidone-iodine 10% Topical Solution

Sunmark Povidone-iodine 10% Topical Solution
SPL v9
SPL
SPL Set ID acc349d6-2875-4814-aa6e-828fffec7f07
Route
TOPICAL
Published
Effective Date 2012-06-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Iodine (1 g)
Inactive Ingredients
Citric Acid Monohydrate Glycerin Nonoxynol-9 Sodium Hydroxide Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2012-06-28

Description

Povidone Iodine 10%  (*Equivalent to 1% titratable Iodine)

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Povidone Iodine 10%  (*Equivalent to 1% titratable Iodine)

Uses

First aid antiseptic to prevent infection in minor cuts, burns.

Section 51945-4

COMPARE TO BETADINE ACTIVE INGREDIENT*   sunmark povidone-iodine 10% Topical Solution  FIRST AID ANTISEPTIC  16 FL OZ (PT) 473mL  *This product is not manufactured or distributed by Purdue Frederick, owner of the registered trademark Betadine

Do Not:
  • use in the eyes.
  • use longer than 1 week unless directed by a doctor.
  • use on individuals who are allergic or sensitive to iodine.
  • apply over large areas of the body.

Warnings

For external use only.

Directions
  • Clean the affected area
  • Apply a small amount on the area 1 to 3 times daily.
  • May be covered with a sterile bandage.
  • If bandaged, let dry first.

Active Ingredient

Povidone Iodine 10%  (*Equivalent to 1% titratable Iodine)

Other Information

Store at room temperature, 20-25 0 C (68-77 0 F).

Inactive Ingredients:

Citric Acid, Disodium Phosphate, Glycerin, Nonoxynol-9, Sodium Hydroxide and Purified Water.

Ask A Doctor in Case Of:
  • deep or puncture wounds
  • animal bites
  • serious burns.

Keep Out of Reach of Children.

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Stop Use and Consult A Doctor If
  • condition persists or gets worse.
  • irritation and redness develop and persist for more than 72 hours.

Sunmark Povidone Iodine 10% Topical Solution



Sunmark Povidone Iodine 10% Topical Solution 8oz (49348 622 37) | Sunmark Povidone Iodine 10% Topical Solution 16oz (49348 622 38)


Structured Label Content

Uses

First aid antiseptic to prevent infection in minor cuts, burns.

Section 51945-4 (51945-4)

COMPARE TO BETADINE ACTIVE INGREDIENT*   sunmark povidone-iodine 10% Topical Solution  FIRST AID ANTISEPTIC  16 FL OZ (PT) 473mL  *This product is not manufactured or distributed by Purdue Frederick, owner of the registered trademark Betadine

Do Not: (Do not:)
  • use in the eyes.
  • use longer than 1 week unless directed by a doctor.
  • use on individuals who are allergic or sensitive to iodine.
  • apply over large areas of the body.

Purpose

Antiseptic

Warnings

For external use only.

Directions
  • Clean the affected area
  • Apply a small amount on the area 1 to 3 times daily.
  • May be covered with a sterile bandage.
  • If bandaged, let dry first.

Active Ingredient

Povidone Iodine 10%  (*Equivalent to 1% titratable Iodine)

Other Information

Store at room temperature, 20-25 0 C (68-77 0 F).

Inactive Ingredients:

Citric Acid, Disodium Phosphate, Glycerin, Nonoxynol-9, Sodium Hydroxide and Purified Water.

Ask A Doctor in Case Of: (Ask a doctor in case of:)
  • deep or puncture wounds
  • animal bites
  • serious burns.

Keep Out of Reach of Children. (Keep out of reach of children.)

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Stop Use and Consult A Doctor If (Stop use and consult a doctor if)
  • condition persists or gets worse.
  • irritation and redness develop and persist for more than 72 hours.

Sunmark Povidone Iodine 10% Topical Solution (sunmark Povidone-Iodine 10% Topical Solution)



Sunmark Povidone Iodine 10% Topical Solution 8oz (49348 622 37) | Sunmark Povidone Iodine 10% Topical Solution 16oz (49348 622 38) (sunmark Povidone-Iodine 10% Topical Solution 8oz (49348-622-37) | sunmark Povidone-Iodine 10% Topical Solution 16oz (49348-622-38))


Advanced Ingredient Data


Raw Label Data

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