CREME 21 HAND SANITIZER GERM PROTECTION WITH ALOE VERA AND GLYCERIN- alcohol gel

Creme 21 hand sanitizer germ protection with aloe vera and glycerin by

Drug Labeling and Warnings

Creme 21 hand sanitizer germ protection with aloe vera and glycerin by is a Otc medication manufactured, distributed, or labeled by Creme 21 GmbH, RNA PHARMA, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ALCOHOL 70% 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

Do not use
In children less than 2 months of age
On open skin wounds

KEEP OUT OF REACH OF CHILDREN

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

WHEN USING

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

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), Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, Aminomethyl Propanol, Caprylyl Glycol, Fragrance, Glycerin, Isopropyl alcohol, Isopropyl Myristate, Tocopheryl acetate.

INSTRUCTIONS FOR USE

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 not available.

INDICATIONS & USAGE

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

DOSAGE & ADMINISTRATION

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CREME 21 HAND SANITIZER GERM PROTECTION WITH ALOE VERA AND GLYCERIN 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73797-103
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
WATER (UNII: 059QF0KO0R)
CARBOMER INTERPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 132584PQMO)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73797-103-07	60 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/03/2020
2	NDC: 73797-103-08	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/03/2020
3	NDC: 73797-103-09	240 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/03/2020
4	NDC: 73797-103-10	480 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/03/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	05/03/2020

Labeler - Creme 21 GmbH (315190250)

Registrant - Creme 21 GmbH (315190250)

Establishment
Name	Address	ID/FEI	Business Operations
RNA PHARMA, LLC		079103999	manufacture(73797-103)