KATRA HAND SANITIZER: Package Insert and Label Information

KATRA HAND SANITIZER- alcohol spray
THS COSMETIC EOOD

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 75% v/v

PURPOSE:

Antiseptic

USES:

To decrease germs on the skin. Hand Sanitizer to help reduce germs that potentially can cause diseases.

WARNING:

FOR EXTERNAL USE ONLY: HANDS
Flammable. Keep away from fire, heat or flame.

Do not use near eyes. In case of contact, rinse eyes thoroughly with water. On children less than 2 months of age. On open skin wounds.
Stop use and ask a doctor if redness or irritation develop and persist for more than 72 hours. If swallowed — get medical help or contact a Poison Control Center right away.

Keep out of reach of children . If swallowed get medical help or contact a Poison Control Center right away.

DIRECTIONS:

Place enough of product on hands. Rub hands together until dry. Supervise children under 6 years of age to avoid swallowing.

OTHER INFORMATION:

Store between 59°F and 86°F (15°C — 30°C), not above 104°F (40°C).

INACTIVE INGREDIENTS:

Distilled water, Glycerin, Chamomilla Recutita Flower Extract, Fragrance.

WITH CHAMOMILE EXTRACT

no rinsing

kills 99.95% of common bacteria

75 % alcohol

beclean

KILLS 99.95% OF MANY COMMON HARMFUL GERMS AND BACTERIA.

Made in EUROPEAN UNION

Distributed by: V&G COMMERCE LLC

881 N. Central Ave; Wood Dale, Il 60191,

Phone: (630) 350-9133

Any questions: www.sanitizers.katratrade.com

Packaging

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KATRA HAND SANITIZER
ethyl alcohol spray
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:81103-002
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 75 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER
GLYCERIN
CHAMOMILE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:81103-002-24 240 mL in 1 BOTTLE, SPRAY None
2 NDC:81103-002-10 1000 mL in 1 BOTTLE, SPRAY None
3 NDC:81103-002-50 5000 mL in 1 CONTAINER None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 11/23/2020
Labeler — THS COSMETIC EOOD (503619953)
Establishment
Name Address ID/FEI Operations
THS COSMETIC EOOD 503619953 manufacture (81103-002)

Revised: 11/2020 THS COSMETIC EOOD

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