DEVOLVER HAND SANITIZER- alcohol gel 
Devolver Cosmetics Co.,Ltd

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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75001-010

ACTIVE INGREDIENT

Active ingredients
ETHANOL 70%

INACTIVE INGREDIENT

Inactive ingredients
Water, Glycerin, Carbomer, Trolamine, Aloe Extract, Parsley Extract, Orange Oil, Limonene

PURPOSE

Purpose: ANTISEPTIC

WARNINGS

Warnings

For external use only. Flammable. Keep away from heat or flame
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Do not use
• in children less than 2 months of age
• on open skin wounds
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When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
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Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Uses

Uses
Hand sanitizer to help reduce bacteria that potentially can cause disease.

Directions

Directions
• Wet hands thoroughly with product and allow to dry without wiping - For children under 6, use only under adult supervision.

Other information

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

PACKAGE LABEL - Devolver Hand Sanitizer Gel 100mL

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PACKAGE LABEL - Devolver Hand Sanitizer Gel 236mL

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PACKAGE LABEL - Devolver Hand Sanitizer Gel 500mL

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Package Label

500ml NDC: 75001-010-04 Label

500ml NDC: 75001-010-05 Label

500ml NDC: 75001-010-06 Label

DEVOLVER HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75001-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
TROLAMINE (UNII: 9O3K93S3TK)  
ALOE (UNII: V5VD430YW9)  
PARSLEY (UNII: 58FMD0Q0EV)  
ORANGE OIL (UNII: AKN3KSD11B)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75001-010-01100 mL in 1 TUBE; Type 0: Not a Combination Product04/01/2020
2NDC:75001-010-02236 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/01/2020
3NDC:75001-010-03500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/01/2020
4NDC:75001-010-04500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/09/2020
5NDC:75001-010-05500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/09/2020
6NDC:75001-010-06500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/09/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E04/01/2020
Labeler - Devolver Cosmetics Co.,Ltd (695733244)
Registrant - Devolver Cosmetics Co.,Ltd (695733244)
Establishment
NameAddressID/FEIBusiness Operations
Skin n Skin Co., Ltd.631090037manufacture(75001-010)

Revised: 6/2020
Document Id: a7a82f7a-8ce4-d578-e053-2995a90ae353
Set id: f2a055b5-b2ff-4840-af2a-5aed59f252cf
Version: 2
Effective Time: 20200609
 
Devolver Cosmetics Co.,Ltd