Active Ingredient(S)
Isopropyl Alcohol 70% v/v. Purpose: Antiseptic
Germs Out
FDA Label NDC 79878-003
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Penseur Products Group Llc for the product Germs Out (NDC 79878-003). 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 active ingredient(s), purpose, use, warnings, do not use, otc - when using, otc - stop use, 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
ANTIMICROBIAL
Use
First Aid to help prevent the risk of infection in minor cuts, scrapes, and burns.
Warnings
For external use only.
If taken internally, serious gastric disturbances will result.
Flammable. Keep away from fire or flame
use only in a well-ventilated area; fumes may be toxic.
Do Not Use
Ask a doctor before use if you have deep or puncture wounds, animal bites, or serious burns.
Otc - When Using
When using this product do not get into eyes.
Do not apply over large areas of the body.
Do not use longer than one week unless directed by a doctor.
Stop use and ask a doctor if condition persists or gets worse.
Keep out of reach of children. In case of infestion get medical help or contact a Poison Control Center right away (1-800-222-1222) or 911.
Otc - Stop Use
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Otc - 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.
Directions
- Clean affected area.
- Apply small amount of this product on the area 1-3 times daily.
- if bandaged, let dry first.
- may be covered with a sterile bandage.
Other Information
- Store between 15-30C (59-86F)
- Avoid freezing and excessive heat above 40C (104F)
Inactive Ingredients
glycerin, hydrogen peroxide, purified water USP
Package Label - Principal Display Panel
236 ml NDC: 79878-003-00
3785 ml NDC: 79878-003-01
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