BLOSSOM ANTIBACTERIAL HAND SANITIZER: Package Insert and Label Information

BLOSSOM ANTIBACTERIAL HAND SANITIZER- alcohol gel
FANTASY FILES, 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 Ingredients

Ethyl Alcohol 62%

Purpose

Antibacterial

Uses

For hand washing to decrease bacteria on skin.

Warnings

Flammable. Keep away from fire or flame.

For external use only.

When using this product

Keep out of eyes. In case of contact with eyes rinse with water.

Stop use and ask doctor if irritation and redness develops and persists.

Keep out of reach of children. If swallowed, get medical help promptly and contact Poison Control.

Directions

Wet hands thoroughly with product and allow to dry without wiping.

Other Information

Store under 105° F

Inactive Ingredients

Carbomer, Fragrance, Glycerin, Propylene Glycol, Tocopheryl Acetate, Triethanolamine, Water.

Questions or Comment?

www.blossombeauty.com
(818) 361-5200

Distributed By: Fantasy Files, LLC
San Fernando, CA 91340

PRINCIPAL DISPLAY PANEL — 58 mL Bottle Label

BLOSSOM®

ANTIBACTERIAL
HAND
SANITIZER

2 fl. oz./58 mL

PRINCIPAL DISPLAY PANEL -- 58 mL Bottle Label
(click image for full-size original)
BLOSSOM ANTIBACTERIAL HAND SANITIZER
alcohol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:80583-110
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Alcohol (Alcohol) Alcohol 62 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE
GLYCERIN
PROPYLENE GLYCOL
.ALPHA.-TOCOPHEROL ACETATE
TROLAMINE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:80583-110-58 58 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part333E 09/01/2020
Labeler — FANTASY FILES, LLC (603581690)
Establishment
Name Address ID/FEI Operations
ZHEJIANG AYAN BIOTECH CO., LTD. 544377996 MANUFACTURE (80583-110)

Revised: 02/2021 FANTASY FILES, LLC

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