GERMASAFE- hand sanitizer gel 
GERMASAFE- hand sanitizer spray 
R AND R- hand sanitizer spray 
Rich & Ruitz Perfumes Industry LLC

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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Hand Sanitizer

HAND SANITIZER

100ml Germasafe Spray Label100ml R&R Spray Label3ml Gel Label60ml Gel Label200ml Gel Label250ml Gel Label500ml Gel Label

GERMASAFE HAND SANITIZER GEL

Germasafe Gel's Active Ingredient is Alcohol 78% v/v

GERMASAFE HAND SANITIZER SPRAY

Alcohol 80% v/v

HAND SANITIZERS

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition. Contained in labels for Germasafe Gel (60ml, 200ml, 250ml, 500ml), Germasafe Spray (100ml) and R&R Spray (100ml)

HAND SANITIZER

Contained in all Germasafe and R&R products:

Do not use:

  • in children less than 2 months of age.
  • on open skin wounds.

HAND SANITIZER

Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away. Contained in all Germasafe and R&R products.

HAND SANITIZER

Purpose: Antiseptic

Contained in all Germasafe and R&R products.

HAND SANITIZER

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition. Contained in labels of all Germasafe and R&R products.

HAND SANITIZER

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

Contained on labels of all Germasafe and R&R products.

HAND SANITIZER, GEL

Directions:

  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.

HAND SANITIZER, SPRAY

Directions:

  • Hold 15cm/6inch from the hands and spray.
  • Place enough prouct on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.

HAND SANITIZER

Inactive ingredients: Butane, Fragrance, Glycerin, Isobutane, Propane, Purified Water USP.

HAND SANITIZER

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

HAND SANITIZER GEL

Directions:

Place enough product on hands to cover all surfaces. Rub hands together until dry.
Supervise children under 6 years of age when using this product to avoid swallowing.

HAND SANITIZER SPRAY

Directions:

Hold 15cm/6inch from the hands and spray.
Place enough prouct on hands to cover all surfaces. Rub hands together until dry.
Supervise children under 6 years of age when using this product to avoid swallowing.

HAND SANITIZER

Other Information:

  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)

HAND SANITIZER

Warnings:

For external use only. Extremely Flammable. Pressurized container. Protect from direct sunlight and do not expose to temperatures exceeding 40C (104F). Keep away from flame and sources of heat and electrical appliances during storage and use. Do not use near flame, incandescent material or any source of combustion - no smoking. Keep away from eyes and do not directly inhale.

GERMASAFE 
hand sanitizer gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76739-005
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL78 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
TROLAMINE (UNII: 9O3K93S3TK) 0.143 mL  in 100 mL
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 1.966 mL  in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.127 mL  in 100 mL
FRAGRANCE LAVENDER & CHIA F-153480 (UNII: SXS9CO2TZK) 0.102 mL  in 100 mL
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) 0.011 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 1.475 mL  in 100 mL
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO) 0.248 mL  in 100 mL
WATER (UNII: 059QF0KO0R) 17.667 mL  in 100 mL
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76739-005-0160 mL in 1 BOTTLE; Type 0: Not a Combination Product12/13/2020
2NDC:76739-005-02200 mL in 1 BOTTLE; Type 0: Not a Combination Product12/13/2020
3NDC:76739-005-03250 mL in 1 BOTTLE; Type 0: Not a Combination Product12/13/2020
4NDC:76739-005-04500 mL in 1 BOTTLE; Type 0: Not a Combination Product12/13/2020
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A12/13/202009/28/2022
GERMASAFE 
hand sanitizer spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76739-006
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
3-((L-MENTHYL)OXY)PROPANE-1,2-DIOL (UNII: KD6TZ2QICH) 16.44 mL  in 100 mL
BUTANE (UNII: 6LV4FOR43R) 16.44 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 0.74 mL  in 100 mL
FRAGRANCE LAVENDER & CHIA F-153480 (UNII: SXS9CO2TZK) 0.05 mL  in 100 mL
WATER (UNII: 059QF0KO0R) 2.67 mL  in 100 mL
ISOBUTANE (UNII: BXR49TP611) 16.44 mL  in 100 mL
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76739-006-01100 mL in 1 BOTTLE; Type 0: Not a Combination Product12/13/2020
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A12/13/202009/28/2022
R AND R 
hand sanitizer spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76739-007
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ISOBUTANE (UNII: BXR49TP611) 16.44 mL  in 100 mL
3-((L-MENTHYL)OXY)PROPANE-1,2-DIOL (UNII: KD6TZ2QICH) 16.44 mL  in 100 mL
BUTANE (UNII: 6LV4FOR43R) 16.44 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 0.74 mL  in 100 mL
FRAGRANCE LAVENDER & CHIA F-153480 (UNII: SXS9CO2TZK) 0.05 mL  in 100 mL
WATER (UNII: 059QF0KO0R) 2.67 mL  in 100 mL
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76739-007-01100 mL in 1 BOTTLE; Type 0: Not a Combination Product12/13/2020
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A12/13/202009/28/2022
GERMASAFE 
hand sanitizer gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76739-008
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL78 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
TROLAMINE (UNII: 9O3K93S3TK) 0.143 mL  in 100 mL
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) 0.011 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 1.475 mL  in 100 mL
FRAGRANCE LAVENDER & CHIA F-153480 (UNII: SXS9CO2TZK) 0.102 mL  in 100 mL
WATER (UNII: 059QF0KO0R) 17.667 mL  in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.127 mL  in 100 mL
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO) 0.248 mL  in 100 mL
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 1.966 mL  in 100 mL
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76739-008-013 mL in 1 PACKET; Type 0: Not a Combination Product12/13/2020
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A12/13/202009/28/2022
Labeler - Rich & Ruitz Perfumes Industry LLC (851721107)
Registrant - Rich & Ruitz Perfumes Industry LLC (851721107)
Establishment
NameAddressID/FEIBusiness Operations
Rich & Ruitz Perfumes Industry LLC851721107manufacture(76739-005, 76739-006, 76739-007, 76739-008)

Revised: 9/2022
Document Id: e9c8927f-bb76-f254-e053-2995a90a692b
Set id: a45f05c5-0780-ef72-e053-2995a90ac8c6
Version: 8
Effective Time: 20220928
 
Rich & Ruitz Perfumes Industry LLC