CREME 21 ANTIBACTERIAL TURMERIC HAND SANITIZER GEL- alcohol gel

Creme 21 Antibacterial Turmeric Hand Sanitizer Gel by

Drug Labeling and Warnings

Creme 21 Antibacterial Turmeric Hand Sanitizer Gel 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]

ALCOHOL 65% v/v......... antimicrobial

ASK DOCTOR

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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

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

Inactive Ingredients
Ingredient Name	Strength
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)

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

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

Labeler - Creme 21 GmbH (315190250)

Registrant - Creme 21 GmbH (315190250)

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