POVIDONE IODINE- povidone iodine gargle 0.5% liquid

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Humco Holding Group, Inc.

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Antiseptic For the temporary relief of occasional sore throat. Symptoms do not improve in 7 days. Irritation, pain or redness persists or worsens. Swelling, rash or fever develops. - For more than 7 days unless directed by a dentist or doctor. - If you are allergic to povidone-iodine or any other ingredients in this product. - If you have any thyroid conditions.

Authorization status:

OTC monograph not final

Summary of Product characteristics

POVIDONE IODINE- POVIDONE IODINE GARGLE 0.5% LIQUID
HUMCO HOLDING GROUP, INC.
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PRIVATE LABEL POVIDONE IODINE GARGLE 0.5%
Drug Facts
ACTIVE INGREDIENT
Povidone-Iodine 0.5%
(0.05% available iodine)
PURPOSE
Antiseptic
USE
For the temporary relief of occasional sore throat.
WARNINGS
Severe or persistent sore throat or sore throat accompanied by high
fever, headache,
nausea and voniting may be serious. Consult a doctor promptly. Do not
use more than
2 days or administer to children under 3 years of age unless directed
by a doctor.
STOP USE AND CONSULT A DOCTOR IF
Symptoms do not improve in 7 days.
Irritation, pain or redness persists or worsens.
Swelling, rash or fever develops.
WHEN USING THIS PRODUCT DO NOT
Get into eyes. If contact occurs, rinse eyes thoroughly with water. If
iritation persists,
consult a doctor.
Swallow.
Use with hydrogen peroxide.
KEEP OUT OF REACH OF CHILDREN.
In case more than used for gargling is swallowed, get medical help or
contact a Poison
Control Center immediately.
DIRECTIONS
DO NOT SWALLOW
Adults and children 12 years and older:
Gargle with 10mL full strength for 30 seconds, then spit out.
Use only with dosing cup provided.
Use up to 4 times daily.
Children under 12:
Do not use.
OTHER INFORMATION
Store at 25°C (77°F); Excursions permitted between 15°C and 30°C
(59°F-86°F).
May stain clothing or dental work.
Avoid contact with jewelry, especially silver.
INACTIVE INGREDIENTS
Citric acid, flavor, glycerin, propylene glycol, purified water,
saccarin sodium, sodium
hydroxide.
DO NOT USE THIS PRODUCT
For more than 7 days unless directed by a dentist or doctor.
If you are allergic to povidone-iodine or any other ingredients in
this product.
If you have any thyroid conditions.
IF PREGNANT OR BREAST-FEEDING
Ask a health professional before use.
PURDUE GARGLE LABEL
POVIDONE IODINE
povidone iodine gargle 0.5% liquid
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:0395-9128
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS