SAFESHA LAVENDER- moisturizing hand sanitizer liquid 
SAFESHA SWEET ORANGE- moisturizing hand sanitizer liquid 
SAFESHA UNFRAGRANCED- moisturizing hand sanitizer liquid 
Safesha, 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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Warnings

<p class="First"><span style="text-decoration: underline;"><strong>For external use only.</strong></span></p><p class="First"><strong>This product is flammable. Keep away from heat and open flame.</strong><span style="text-decoration: underline;"><strong></strong></span></p><p class="First">If this product comes in contact with eyes, rinse thoroughly with water.</p><p class="First">If irritation persists, stop use and contact a doctor.</p><p class="First">Keep out of reach of children<br></p>

Image Components: White tube with purple cap and wrap label.

Apply solution to hands and rub until dry.

Apply solution to hand and rub until dry.

Apply solution to hands and rub until dry.

Apply solution to hands and rub until dry.

Apply solution to hands and rub until dry.

Apply solution to hands and rub until dry.

Apply solution to hands and rub until dry.

Apply solution to hands and rub until dry.

Safesha Moisturizing Hand Sanitizer with Olive Oil (Lavender)

Kills 99.99% of germs

3 fl. oz. / 89 ml

Uses: To help reduce bacteria on hands and keep hands hydrated.

Directions: Apply solution to hands and rub until dry.

Other Information: Do not store above 105 Label Art

Safesha Moisturizing Hand Sanitizer with Olive Oil (Sweet Orange)

Kills 99.99% of germs

3 fl. oz. / 89 ml

Uses: To help reduce bacteria on hands and keep hands hydrated.

Directions: Apply solution to hands and rub until dry.

Other Information: Do not store above 105 Label Art

Safesha Moisturizing Hand Sanitizer with Olive Oil (Unscented)

Kills 99.99% of germs

3 fl. oz. / 89 ml

Uses: To help reduce bacteria on hands and keep hands hydrated.

Directions: Apply solution to hands and rub until dry.

Other Information: Do not store above 105

Label Art

SAFESHA  LAVENDER
moisturizing hand sanitizer liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69027-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL56.07   in 56.07 
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
ALOE (UNII: V5VD430YW9)  
TOCOPHEROL (UNII: R0ZB2556P8)  
WATER (UNII: 059QF0KO0R)  
AMINOMETHYL PROPANEDIOL (UNII: CZ7BU4QZJZ)  
OLEA EUROPAEA FRUIT VOLATILE OIL (UNII: 8E7358CX1J)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69027-001-011 in 1 TUBE; Type 0: Not a Combination Product07/01/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/01/2014
SAFESHA  SWEET ORANGE
moisturizing hand sanitizer liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69027-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL56.07   in 56.07 
Inactive Ingredients
Ingredient NameStrength
ALOE (UNII: V5VD430YW9)  
TOCOPHEROL (UNII: R0ZB2556P8)  
WATER (UNII: 059QF0KO0R)  
AMINOMETHYL PROPANEDIOL (UNII: CZ7BU4QZJZ)  
GLYCERIN (UNII: PDC6A3C0OX)  
CITRUS AURANTIUM FRUIT OIL (UNII: 59JDQ5VT0T)  
OLEA EUROPAEA FRUIT VOLATILE OIL (UNII: 8E7358CX1J)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69027-002-011 in 1 TUBE; Type 0: Not a Combination Product07/01/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/01/2014
SAFESHA  UNFRAGRANCED
moisturizing hand sanitizer liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69027-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL56.07   in 56.07 
Inactive Ingredients
Ingredient NameStrength
ALOE (UNII: V5VD430YW9)  
TOCOPHEROL (UNII: R0ZB2556P8)  
AMINOMETHYL PROPANEDIOL (UNII: CZ7BU4QZJZ)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
OLEA EUROPAEA FRUIT VOLATILE OIL (UNII: 8E7358CX1J)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69027-003-011 in 1 TUBE; Type 0: Not a Combination Product07/01/2014
2NDC:69027-003-021 in 1 CONTAINER; Type 0: Not a Combination Product10/01/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/01/2014
Labeler - Safesha, LLC (079975761)
Registrant - Safesha, LLC (079975761)
Establishment
NameAddressID/FEIBusiness Operations
Kapra Cosmetics809506223manufacture(69027-001, 69027-002, 69027-003)

Revised: 12/2021
Document Id: b7ab1d87-d8a6-2875-e053-2a95a90a1c25
Set id: 9c0a20be-da37-4a5d-aceb-76ab906d3f0b
Version: 6
Effective Time: 20211227
 
Safesha, LLC