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

----------

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

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.

Creme 21 hand sanitizer germ protection with aloevera and glycerin

CREME 21 HAND SANITIZER GERM PROTECTION WITH ALOE VERA AND GLYCERIN 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73797-103
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL7 mL  in 10 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73797-103-0760 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/03/2020
2NDC:73797-103-08118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/03/2020
3NDC:73797-103-09240 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/03/2020
4NDC:73797-103-10480 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/03/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E05/03/2020
Labeler - Creme 21 GmbH (315190250)
Registrant - Creme 21 GmbH (315190250)
Establishment
NameAddressID/FEIBusiness Operations
RNA PHARMA, LLC079103999manufacture(73797-103)

Revised: 5/2020
Document Id: a4688957-372d-cf26-e053-2995a90a1f13
Set id: a4c250a7-705f-5236-e053-2995a90a39f0
Version: 2
Effective Time: 20200503
 
Creme 21 GmbH