CREME 21 ANTIBACTERIAL TURMERIC HAND SANITIZER GEL- alcohol gel
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 65% 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.

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

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, Carbomer, Curcuma longa extract, Fragrance, Glycerin, Polysorbate 20, Triethanolamine, 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 no available.

Dosage-Gel
Route of administration-Topical

Creme 21 antibacterial turmeric hand sanitizer gel label

CREME 21 ANTIBACTERIAL TURMERIC HAND SANITIZER GEL
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:73797-101
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	6.5 mL in 10 mL

Ingredient Name	Strength
Inactive Ingredients
CARBOMER 940 (UNII: 4Q93RCW27E)
TOCOPHEROL (UNII: R0ZB2556P8)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
TROLAMINE (UNII: 9O3K93S3TK)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
WATER (UNII: 059QF0KO0R)
CURCUMA LONGA WHOLE (UNII: W5488JUO8U)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:73797-101-05	59 mL in 1 TUBE; Type 0: Not a Combination Product	04/22/2020	06/12/2022
2	NDC:73797-101-06	236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/22/2020	06/09/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	04/22/2020	06/12/2022

Labeler - Creme 21 GmbH (315190250)

Registrant - Creme 21 GmbH (315190250)

Name	Address	ID/FEI	Business Operations
Establishment
Helios Perfumes and Cosmetics LLC		851721102	manufacture(73797-101) , analysis(73797-101) , pack(73797-101)

Revised: 10/2021

Document Id: ceee5815-57fa-947d-e053-2995a90a0e97

Set id: a3db6ee8-6075-e325-e053-2a95a90ad5c2

Version: 4

Effective Time: 20211022

Creme 21 GmbH