B4 Antiseptic Hand Sanitizer with Ethyl Alcohol: Package Insert and Label Information

B4 ANTISEPTIC HAND SANITIZER WITH ETHYL ALCOHOL- alcohol gel
Midway Advanced Products, LLC

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.

DRUG FACTS

Active ingredient

Ethyl Alcohol 65% w/w

Purpose

Antimicrobial

Uses

  • to sanitize hands without water
  • kills 99% of most common bacteria

Warnings

FLAMMABLE. For external use only.

When using this product:

  • keep away from fire or flame
  • do not use in eyes
  • discontinue use if irritation or redness develop

Keep out of reach of children.

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

Directions

  • tear open packet and apply entire amount of gel to unsoiled hands
  • rub in thoroughly until hands are dry
  • do not wipe or use water rinse

Other information

  • store at room temperature

Inactive ingredients

Water, Aloe Vera Gel, Carbomer, Diisopropylamine, Glycerin, Isopropyl Myristate, Fragrance, Phenoxyethanol, Tocopheryl Acetate, D&C Yellow # 10, FD&C Yellow #5, FD&C Blue #1

Package Labeling

Image 200
(click image for full-size original)

B4 ANTISEPTIC HAND SANITIZER WITH ETHYL ALCOHOL
ethyl alcohol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:52490-201
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 650 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
ALOE VERA LEAF
CARBOXYPOLYMETHYLENE
DIISOPROPYLAMINE
GLYCERIN
ISOPROPYL MYRISTATE
PHENOXYETHANOL
.ALPHA.-TOCOPHEROL ACETATE
D&C YELLOW NO. 10
FD&C YELLOW NO. 5
FD&C BLUE NO. 1
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52490-201-10 500 CARTON in 1 CARTON contains a CARTON
1 1.2 mL in 1 CARTON This package is contained within the CARTON (52490-201-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333E 02/01/2018
Labeler — Midway Advanced Products, LLC (962765009)

Revised: 02/2018 Midway Advanced Products, LLC

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