SPL v1
SPL
SPL Set ID a81e8dc6-2009-9feb-e053-2995a90ac8b1
Route
TOPICAL
Published
Effective Date 2020-06-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrogen Peroxide (3 mL)
Inactive Ingredients
Water Glycerin Zinc Gluconate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-06-15

Description

hydrogen peroxide 3%

Purpose

Antimicrobial


Medication Information

Purpose

Antimicrobial

Description

hydrogen peroxide 3%

Uses

Hand Sanitizer to reduce bacteria on the skin

Warnings

For external use only: hands

Flammable, keep away from heat and flame.

Directions

Wet hands thoroughly with product and allow to dry without wiping. For children under 6, use only under adult supervision. Not recommended for infants

Package Label

Active Ingredient

hydrogen peroxide 3%

Other Information

Do not store above 105F. May discolor certain fabrics

Inactive Ingredients

Glycerin, Water, Bis(D-gluconato-01, 02)zinc

When Using This Product

Keep out of eyes. In case of contact with eyes, rinse thoroughly with water. Do not inhale or ingest

Stop Use and Ask A Doctor If

Irritation or redness develops. Condition persists for more than 72 hours

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Uses

Hand Sanitizer to reduce bacteria on the skin

Purpose

Antimicrobial

Warnings

For external use only: hands

Flammable, keep away from heat and flame.

Directions

Wet hands thoroughly with product and allow to dry without wiping. For children under 6, use only under adult supervision. Not recommended for infants

Package Label

Active Ingredient (Active ingredient)

hydrogen peroxide 3%

Other Information (Other information)

Do not store above 105F. May discolor certain fabrics

Inactive Ingredients (Inactive ingredients)

Glycerin, Water, Bis(D-gluconato-01, 02)zinc

When Using This Product (When using this product)

Keep out of eyes. In case of contact with eyes, rinse thoroughly with water. Do not inhale or ingest

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

Irritation or redness develops. Condition persists for more than 72 hours

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

If swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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