DELMA- hand sanitizer gel 
Delma Global, Inc

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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Delma Hand Sanitizer with Fragrance

Active Ingredient(s)

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when a soap and water are not available.

Warnings

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

Do not use

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.

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

Other information

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

May discolor certain fabrics or surfaces

Inactive ingredients

aloe barbadensis extract, aminomethyl propanol, carbomer, caprylyl glycol, glycerin, isopropyl alcohol, isopropyl myristate, propylene glycol, tocopheryl acetate, water

Package Label - Principal Display Panel

236 mL NDC: 80208-112-03

236 mL NDC: 80208-112-03

DELMA 
hand sanitizer gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80208-112
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
FRAGRANCE LEMON ORC2001060 (UNII: K1725A7G95)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80208-112-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product08/27/2020
2NDC:80208-112-0259 mL in 1 BOTTLE; Type 0: Not a Combination Product08/27/2020
3NDC:80208-112-03236 mL in 1 BOTTLE; Type 0: Not a Combination Product08/27/2020
4NDC:80208-112-04591 mL in 1 BOTTLE; Type 0: Not a Combination Product08/27/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A08/27/2020
Labeler - Delma Global, Inc (131110987)
Establishment
NameAddressID/FEIBusiness Operations
Ningbo Pasco United Industry Co., Ltd.529035953manufacture(80208-112)

Revised: 1/2022
Document Id: d58e2af9-9d21-bf44-e053-2a95a90aec59
Set id: addbf0fb-c2a7-0c47-e053-2a95a90a98d8
Version: 3
Effective Time: 20220114
 
Delma Global, Inc