Otc - Active Ingredient
Ethanol 70%
Ethanol 70%
Ethanol 70%
Guardrx Unscented Extra Strength
FDA Label NDC 74306-135
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Gps Associates for the product Guardrx Unscented Extra Strength (NDC 74306-135). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, purpose:, uses:, warnings:, otc - when using, otc - do not use, otc - ask doctor, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose:
Antiseptic
Antiseptic
Antiseptic
Uses:
-For hand washing to decrease bacteria on skin.
-Recommended for repeated use.
-For hand washing to decrease bacteria on skin.
-Recommended for repeated use.
-For hand washing to decrease bacteria on skin.
-Recommended for repeated use.
Warnings:
-Flammable, keep away from children.
-Flammable, keep away from children.
-Flammable, keep away from children.
Otc - When Using
-For external use only.
-For external use only.
-For external use only.
Otc - Do Not Use
-Do not use in eyes. If contact occurs, flush thoroughly with water.
-Do not use in eyes. If contact occurs, flush thoroughly with water.
-Do not use in eyes. If contact occurs, flush thoroughly with water.
Otc - Ask Doctor
-Stop use and ask doctor if redness and irritation develop and persist for more than 72 hours.
-Stop use and ask doctor if redness and irritation develop and persist for more than 72 hours.
-Stop use and ask doctor if redness and irritation develop and persist for more than 72 hours.
Otc - Keep Out Of Reach Of Children
-Keep out of reach of children. If swallowed, get medical help or contact the Poison Control Center right away.
-Keep out of reach of children. If swallowed, get medical help or contact the Poison Control Center right away.
-Keep out of reach of children. If swallowed, get medical help or contact the Poison Control Center right away
Directions:
Wet hands thoroughly with product and allow to dry without wiping.
-Do not use other than directed.
Wet hands thoroughly with product and allow to dry without wiping.
-Do not use other than directed.
Wet hands thoroughly with product and allow to dry without wiping.
-Do not use other than directed.
Storage And Handling
Store at room temperature 20-25 °C (66-77 °F)
Store at room temperature 20-25 °C (66-77 °F)
Store at room temperature 20-25 °C (66-77 °F)
Inactive Ingredients:
Aqua, Glycerin, Citrus Aurantium Dulcis (Orange) Peel Oil, Thymus Vulgaris (Red Thyme) Oil, Tocopherol.
Aqua, Glycerin, Lavandula Angustifolia (Lavender) Oil, Mentha Piperita (Peppermint) Oil, Tocopherol.
Aqua, Glycerin, Tocopherol.
59 Ml Ndc: 74306-133-02
Guardrx Red Thyme Extra Strength 2oz 70 (Guardrx Red Thyme 2oz 70)
118 Ml Ndc: 74306-133-04
Guardrx Red Thyme Extra Strength 4oz 70 (Guardrx Red Thyme 4oz 70)
236 Ml Ndc: 74306-133-08
Guardrx Red Thyme Extra Strength 8oz 70 (Guardrx Red Thyme 8oz 70)
59 Ml Ndc: 74306-134-02
Guardrx Lavender Peppermint 2oz 70 (Guardrx Lavender Peppermint 2oz 70)
118 Ml Ndc: 74306-134-04
Guardrx Lavender Peppermint 4oz 70 (Guardrx Lavender Peppermint 4oz 70)
236 Ml Ndc: 74306-134-08
Guardrx Lavender Peppermint 8oz 70 (Guardrx Lavender Peppermint 8oz 70)
59 Ml Ndc: 74306-135-02
Guardrx Unscented 2oz 70 (Guardrx Unscented 2oz 70)
118 Ml Ndc: 74306-135-04
Guardrx Unscented 4oz 70 (Guardrx Unscented 4oz 70)
236 Ml Ndc: 74306-135-08
Guardrx Unscented 8oz 70 (Guardrx Unscented 8oz 70)
* Please review the disclaimer below.
