Creme21 ultra protect travel kit by Creme 21 GmbH

Creme21 ultra protect travel kit by

Drug Labeling and Warnings

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

Drug Details [pdf]

CREME21 ULTRA PROTECT TRAVEL KIT- alcohol, benzalkonium chloride 
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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Creme21 Advanced Moisturizing Hand Sanitizer

Alcohol 70% v/v.........antimicrobial

Creme21 Advanced Moisturizing Sanitizer Spray

Alcohol 70% v/v.........antimicrobial

Creme21 Wet Wipes

Benzalkonium chloride 0.1%.....antimicrobial

Creme21 Advanced Moisturizing Hand Sanitizer

Do not use

In children less than 2 months of age

On open skin wounds

Creme21 Advanced Moisturizing Sanitizer Spray

Do not use

In children less than 2 months of age

On open skin wounds

Creme21 Wet Wipes

Do not use

In children less than 2 months of age

On open skin wounds

Creme21 Advanced Moisturizing Hand Sanitizer

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

Creme21 Advanced Moisturizing Sanitizer Spray

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

Creme21 Wet Wipes

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

Creme21 Advanced Moisturizing Hand Sanitizer

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

Creme21 Advanced Moisturizing Sanitizer Spray

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

Creme21 Wet Wipes

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

Creme21 Advanced Moisturizing Hand Sanitizer

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

Creme21 Advanced Moisturizing Sanitizer Spray

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

Creme21 Wet Wipes

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

Creme21 Advanced Moisturizing Hand Sanitizer

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

Creme21 Advanced Moisturizing Sanitizer Spray

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

Creme21 Wet Wipes

Store at room temperature.

Creme21 Advanced Moisturizing Hand Sanitizer

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

Creme21 Advanced Moisturizing Sanitizer Spray

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

Creme21 Wet Wipes

For external use only.

Creme21 Advanced Moisturizing Hand Sanitizer

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

extract, Polysorbate 20, Triethanolamine, Tocopherol.

Creme21 Advanced Moisturizing Sanitizer Spray

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

extract, Polysorbate 20, Tocopherol

Creme21 Wet Wipes

Aqua (Water), Aloe Barbadensis leaf Extract, Cetylpyridinium Chloride, Citric Acid, Dehydroacetic Acid, Fragrance, Glycerin, Phenoxyethanol, Polysorbate 20, Sodium Benzoate, Sodium Hydroxide.

Creme21 Advanced Moisturizing Hand Sanitizer

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

Creme21 Advanced Moisturizing Sanitizer Spray

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

Creme21 Wet Wipes

USES: To decrease bacteria on the skin that potentially can cause disease. For use when soap and water are not available.

Creme21 Advanced Moisturizing Hand Sanitizer

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

Creme21 Advanced Moisturizing Sanitizer Spray

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

Creme21 Wet Wipes

USES: To decrease bacteria on the skin that potentially can cause disease. For use when soap and water are not available.

Creme21 Advanced Moisturizing Hand Sanitizer

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.

Creme21 Advanced Moisturizing Sanitizer Spray

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.

Creme21 Wet Wipes

Wet hands thoroughly with product and allow to dry.

Open peel off label, gently full it back, remove and use wipe as required.

Reseal back after use to avoid drying of wipes.

Do not flush.

Children under 6 years of age should be supervised when using this product.

Creme 21 KIT label final

CREME21 ULTRA PROTECT TRAVEL KIT 
alcohol, benzalkonium chloride kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 73797-110
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 73797-110-041 in 1 KIT08/27/202009/01/2023
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 10 BOTTLE, PLASTIC 1 mL
Part 20 BOTTLE, PUMP 1 mL
Part 30 PACKET 1 mL
Part 1 of 3
CREME21 ADVANCED MOISTURIZING HAND SANITIZER 
alcohol gel
Product Information
Item Code (Source)NDC: 73797-111
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)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
TROLAMINE (UNII: 9O3K93S3TK)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
GLYCERIN (UNII: PDC6A3C0OX)  
AZADIRACHTA INDICA LEAF (UNII: HKY915780T)  
TOCOPHEROL (UNII: R0ZB2556P8)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 73797-111-0150 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 finalpart333E08/27/202009/01/2023
Part 2 of 3
CREME21 ADVANCED MOISTURIZING SANITIZER 
alcohol spray
Product Information
Item Code (Source)NDC: 73797-112
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)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
TOCOPHEROL (UNII: R0ZB2556P8)  
GLYCERIN (UNII: PDC6A3C0OX)  
AZADIRACHTA INDICA LEAF (UNII: HKY915780T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 73797-112-0250 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E08/27/202009/01/2023
Part 3 of 3
CREME21 WET WIPES 
benzalkonium chloride cloth
Product Information
Item Code (Source)NDC: 73797-113
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.01 g  in 10 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
WATER (UNII: 059QF0KO0R)  
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
GLYCERIN (UNII: PDC6A3C0OX)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 73797-113-0340 mL in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E08/27/202009/01/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E08/27/202009/01/2023
Labeler - Creme 21 GmbH (315190250)
Registrant - Creme 21 GmbH (315190250)

Revised: 10/2021
 

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