Creme21 Antibacterial Ultra Protect Sanitizer by Creme 21 GmbH / Helios Perfumes and Cosmetics LLC

Creme21 Antibacterial Ultra Protect Sanitizer by

Drug Labeling and Warnings

Creme21 Antibacterial Ultra Protect Sanitizer by is a Otc medication manufactured, distributed, or labeled by Creme 21 GmbH, Helios Perfumes and Cosmetics LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

CREME21 ANTIBACTERIAL ULTRA PROTECT SANITIZER- alcohol spray 
Creme 21 GmbH

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.

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ALCOHOL 70% v/v......... antimicrobial

Stop use and ask doctor if irritation or rash occurs. These may be signs of serious condition.

Do not use

In children less than 2 months of age

On open skin wounds

Keep out of children. If swallowed, get medical help or contact a poison control centre right away.

When using this product keep out of eyes, ears and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of serious condition.

​Store between 15 to 30°C (59 to 86° F), Avoid freezing and excessive heat above 40°C (104° F)

For external use only. Flammable. Keep away from heat or flame.

Aqua (Water), Aloe barbadensis leaf extract, Fragrance, Glycerin, Melia azadirachta leaf extract, Polysorbate 20, Tocopherol.

Place enough products on hands to cover all surfaces. Rubs hands together until dry.

Supervise children under 6 years of age when using this products to avoid swallowing.

USES: Hand sanitizer to help reduce bacteria that potentially cause disease. For use when soap and water are not available.

USES: Hand sanitizer to help reduce bacteria that potentially cause disease. For use when soap and water are not available.

Place enough products on hands to cover all surfaces. Rubs hands together until dry.

Supervise children under 6 years of age when using this products to avoid swallowing.

CREME21 ANTIBACTERIAL ULTRA PROTECT SANITIZER 
alcohol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73797-105
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	7 mL  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
POLYSORBATE 20 (UNII: 7T1F30V5YH)
TOCOPHEROL (UNII: R0ZB2556P8)
AZADIRACHTA INDICA LEAF (UNII: HKY915780T)
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73797-105-14	118.28 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/18/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	07/18/2020	08/26/2022

Labeler - Creme 21 GmbH (315190250)

Registrant - Creme 21 GmbH (315190250)

Establishment
Name	Address	ID/FEI	Business Operations
Helios Perfumes and Cosmetics LLC		851721102	manufacture(73797-105) , analysis(73797-105) , pack(73797-105)

Revised: 10/2021

Document Id: ceeda66a-fc61-ac57-e053-2995a90ae753

34390-5

Set id: aab5f8e1-6c9f-3db0-e053-2a95a90ada3d

Version: 3

Effective Time: 20211022