DEVOLVER PREMIUM GEL- 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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Active ingredient

Ethyl Alcohol 70%

Purpose

Antiseptic

Use

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

Warnings

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

Do not use

in children less than 2 months of age

on open skin wounds

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 a serious condition.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Wet hands thoroughly with product and allow to dry without wiping.

For children under 6, use only under adult supervision.

Other information

Store between 15-30C (59-86F)

Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

Purified Water, Glycerin, Carbomer, Fragrance, Trolamine, Aleo Extract(09), Parsley Extract

Package Label

60ml NDC: 75001-201-01 Label

100ml NDC: 75001-201-02 Label

236ml NDC: 75001-201-03 Label

500ml NDC: 75001-201-04 Label

3785ml NDC: 75001-201-05 Label

120ml NDC: 75001-201-06 Label

350ml NDC: 75001-201-07 Label

300ml NDC: 75001-201-08 Label

DEVOLVER PREMIUM GEL 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75001-201
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70.00075 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
FRAGRANCE LAVENDER & CHIA F-153480 (UNII: SXS9CO2TZK)  
TROLAMINE (UNII: 9O3K93S3TK)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
PETROSELINUM CRISPUM (UNII: 1WZA4Y92EX)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75001-201-0160 mL in 1 BOTTLE; Type 0: Not a Combination Product05/08/2020
2NDC:75001-201-02100 mL in 1 BOTTLE; Type 0: Not a Combination Product05/08/2020
3NDC:75001-201-03236 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/08/2020
4NDC:75001-201-04500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/08/2020
5NDC:75001-201-053785 mL in 1 BOTTLE; Type 0: Not a Combination Product05/08/2020
6NDC:75001-201-06120 mL in 1 BOTTLE; Type 0: Not a Combination Product06/02/2020
7NDC:75001-201-07350 mL in 1 BOTTLE; Type 0: Not a Combination Product06/02/2020
8NDC:75001-201-08300 mL in 1 BOTTLE; Type 0: Not a Combination Product06/02/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/08/2020
Labeler - Devolver Cosmetics Co., Ltd (695733244)
Registrant - Devolver Cosmetics Co., Ltd (695733244)
Establishment
NameAddressID/FEIBusiness Operations
Devolver Cosmetics Co., Ltd695733244manufacture(75001-201)

Revised: 6/2020
Document Id: a718fcbb-20ed-4230-e053-2995a90a0961
Set id: a4a675f8-5edb-6aa0-e053-2995a90a6280
Version: 2
Effective Time: 20200602
 
Devolver Cosmetics Co., Ltd