CREME 21 HAND SANITIZER- alcohol gel

CREME 21 HAND SANITIZER by

Drug Labeling and Warnings

CREME 21 HAND 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]

ACTIVE INGREDIENT

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

ASK DOCTOR

DO NOT USE

Do not use

In children less than 2 months of age

On open skin wounds

WHEN USING

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

KEEP OUT OF REACH OF CHILDREN

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

INDICATIONS & USAGE

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

STOP USE

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

OTHER SAFETY INFORMATION

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

WARNINGS

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

INACTIVE INGREDIENT

Aqua (water), Aloe barbadensis leaf extract, Carbomer, Fragrance, Glycerin, Melia azadirachta leaf extract, 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.

PURPOSE

USES: Hand sanitizer to help reduce bacteria that potentially cause disease. For use when soap and water are no available.

DOSAGE & ADMINISTRATION

Dosage-Gel

Route of administration-Topical

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CREME 21 HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73797-100
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
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
TROLAMINE (UNII: 9O3K93S3TK)
CARBOMER 940 (UNII: 4Q93RCW27E)
MELIA AZEDARACH LEAF (UNII: 8194E3H7D4)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
TOCOPHEROL (UNII: R0ZB2556P8)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73797-100-01	50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/01/2020
2	NDC: 73797-100-02	59 mL in 1 TUBE; Type 0: Not a Combination Product	04/01/2020
3	NDC: 73797-100-03	236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	04/01/2020

Labeler - Creme 21 GmbH (315190250)

Registrant - Creme 21 GmbH (315190250)

Establishment
Name	Address	ID/FEI	Business Operations
Helios Perfumes and Cosmetics LLC		851721102	manufacture(73797-100) , analysis(73797-100) , pack(73797-100)

Establishment
Name	Address	ID/FEI	Business Operations
ACCRA PAC (INDIA) PRIVATE LIMITED		859652454	manufacture(73797-100)