HAND SANITIZER- alcohol gel
Billion Internet Group SA de CV
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
----------
This is a hand sanitizer manufactured according to the
Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.
The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:
- Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (70%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
- glycerin
- triethanolamine
- Carbomer
- purified water USP
The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.
Active Ingredient(s)
Alcohol 70% v/v. Purpose: Antiseptic
Purpose
Antiseptic, Hand Sanitizer
Use
Decrease bacteria on skin
Warnings
For external use only. Flammable. Keep away from heat or flame
Do not use
Stop use and ask a doctor if redness or irritation
develops and persists for more than 72 hours.
When using this product, avoid contact with eyes.In
case of contact flush eyes with water.
Keep out of reach of children. If swallowed, get
medical help or contact a Poison Control Center right away.
Stop use and ask a doctor if redness or irritation
develops and 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.
Directions
- Directions: Wet hands thoroughly with product, rub,
and allow to dry. Children under 6 years of age, use only
under adult supervision.
Other information
- Do not store above 105°F (43°C). May discolor some fabrics and surfaces.
Inactive ingredients
WATER (AQUA), CARBOMER, TRIETHANOLAMINE,
GLYCERIN.
Package Label - Principal Display Panel
5000 mL NDC: 76708-111-05
4000 mL NDC: 76708-113-04
20000 mL NDC: 76708-114-20
250 mL NDC: 76708-112-25