Creme21 kit pack by Creme 21 GmbH

Creme21 kit pack by

Drug Labeling and Warnings

Creme21 kit pack by is a Otc medication manufactured, distributed, or labeled by Creme 21 GmbH. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

CREME21 KIT PACK- alcohol 
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 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.

Creme 21 antibacterial sanitizer-Aqua (water), Aloe barbadensis leaf juice, Aminomethyl propanol, Caprylyl glycol,Glycerin, Isopropyl alcohol, Isopropyl myristate,Tocopheryl acetate.

Creme 21 hand sanitizer germ protection with aloe vera and glycerin-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 kit pack

CREME21 KIT PACK 
alcohol kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 73797-120
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 73797-120-201 in 1 KIT08/01/2020
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 10 BOTTLE, PLASTIC 1 mL
Part 20 BOTTLE, SPRAY 1 mL
Part 1 of 2
CREME 21 HAND SANITIZER GERM PROTECTION WITH ALOE VERA AND GLYCERIN 
alcohol gel
Product Information
Item Code (Source)NDC: 73797-122
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
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
WATER (UNII: 059QF0KO0R)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
(C10-C30)ALKYL METHACRYLATE ESTER (UNII: XH2FQZ38D8)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 73797-122-2281 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E08/03/2020
Part 2 of 2
CREME 21 ANTIBACTERIAL SANITIZER 
alcohol spray
Product Information
Item Code (Source)NDC: 73797-121
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
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
WATER (UNII: 059QF0KO0R)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 73797-121-2171 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E08/03/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E08/01/202008/01/2020
Labeler - Creme 21 GmbH (315190250)
Registrant - Creme 21 GmbH (315190250)

Revised: 10/2021
 

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