DELMA- hand sanitizer gel

Delma by

Drug Labeling and Warnings

Delma by is a Otc medication manufactured, distributed, or labeled by Delma Global, Inc, Ningbo Pasco United Industry Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

WHEN USING

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

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.

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.

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

INGREDIENTS AND APPEARANCE

DELMA 
hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80208-112
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80208-112-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/27/2020
2	NDC: 80208-112-02	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/27/2020
3	NDC: 80208-112-03	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/27/2020
4	NDC: 80208-112-04	591 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/27/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	08/27/2020

Labeler - Delma Global, Inc (131110987)

Establishment
Name	Address	ID/FEI	Business Operations
Ningbo Pasco United Industry Co., Ltd.		529035953	manufacture(80208-112)