75% ALCOHOL INSTANT HAND SANITIZER- 75% alcohol instant hand sanitizer spray 
Ganzhou Hongda Biochemical and Industrial Chemical 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.

----------

75% Alcohol Instant Hand Sanitizer Spray

Active Ingredient(s)

75% Ethyl alcohol

Purpose

Kills more than 99.9% of germs; waterless gel

Use

Put a dime-size amount in your palm and briskly rub your hands until dry

Warnings

For external use only. Flammable. Keep away from

heat or flame

Do not use

1, In children less than 2 months of age.
2, On open skin wounds.

1, When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
2, Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
3, 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

1, Place enough product on hands to cover all surfaces. Rub hands together until dry.
2, Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

Inactive ingredients

purified water

Package Label - Principal Display Panel

10025050

75% ALCOHOL INSTANT HAND SANITIZER 
75% alcohol instant hand sanitizer spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78412-006
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78412-006-0150 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
2NDC:78412-006-02100 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
3NDC:78412-006-03250 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/30/2020
Labeler - Ganzhou Hongda Biochemical and Industrial Chemical Co., Ltd (554534260)
Establishment
NameAddressID/FEIBusiness Operations
Ganzhou Hongda Biochemical and Industrial Chemical Co., Ltd554534260manufacture(78412-006)

Revised: 5/2020
Document Id: a6b281df-665b-cc94-e053-2995a90a0da6
Set id: a6b283c0-279b-cd5f-e053-2995a90ab343
Version: 1
Effective Time: 20200528
 
Ganzhou Hongda Biochemical and Industrial Chemical Co., Ltd