cr-5667761, ndc 70000-0060-1

cr-5667761, ndc 70000-0060-1
SPL v6
SPL
SPL Set ID b023e2e3-a4af-eb19-e053-2995a90a7c6e
Route
topical
Published
Effective Date 2020-09-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
iodine (10 mg)
Inactive Ingredients
glycerin water polysorbate 80 sodium citrate anhydrous citric acid sodium phosphate, dibasic, anhydrous

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2020-09-25
Purpose

Healthcare Antiseptic

Description

For external use only

Medication Information

Warnings

For external use only

Purpose

Healthcare Antiseptic

Directions

Clean the area. Apply product to the operative site prior to surgery.

Inactive Ingredients

Citric Acid Anhydrous, Disodium Phosphate Anhydrous, Glycerin, Polysorbate 80, Puried Water, Sodium Citrate USP

Description

For external use only

Questions?

1-888-396-2739

Use

For preparation of the skin prior to surgery. Helps reduce bacteria that potentially can cause skin infection

Other

Store at controlled room temperature 15º-30ºC (59º-86ºF).

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Labeling

Do Not Use
  • if allergic to iodine
  • in the eyes
Active Ingredient

Povidone-iodine 10%

Stop Use and Ask A Doctor If
  • irritation and redness develop
  • condition persists for more than 72 hours

Structured Label Content

Warnings

For external use only

Purpose

Healthcare Antiseptic

Directions

Clean the area. Apply product to the operative site prior to surgery.

Inactive Ingredients

Citric Acid Anhydrous, Disodium Phosphate Anhydrous, Glycerin, Polysorbate 80, Puried Water, Sodium Citrate USP

Questions?

1-888-396-2739

Use

For preparation of the skin prior to surgery. Helps reduce bacteria that potentially can cause skin infection

Other

Store at controlled room temperature 15º-30ºC (59º-86ºF).

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Labeling

Do Not Use
  • if allergic to iodine
  • in the eyes
Active Ingredient

Povidone-iodine 10%

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • irritation and redness develop
  • condition persists for more than 72 hours

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:21.344544 · Updated: 2026-03-14T23:10:42.831626