BIONAMICS- ethyl alcohol spray 
ALA MEDICAL GROUP PTY 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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BIONAMICS

Active lngredient  

Ethyl Alcohol

Purpose 

Antiseptic 

Uses 


Hand sanitiser to help reduce bacteria that potentially

can cause disease. For use when soap and water are not available.

Recommended for repeated use.

Warnings  

For external use only. Flammable.
Keep away from fire and flame.

Do not use  - in children less than 2 months of age.
                   - on open skin wounds.

When usin g this product Avoid contact with eyes. In case of eye
contact, rinse with water immediately.

Stop use and ask a doctor if irritation and rash appears and lasts.

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

Directions

Inactive ingredients

 Water, Glycerin, Tocopherol Acetate.

Keep out of re ach of children

If swallowed, get medical help or contact a Poison Control Centre immediately.

Products Labels

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BIONAMICS 
ethyl alcohol spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74198-002
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)  
GLYCERIN (UNII: PDC6A3C0OX)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74198-002-0150 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/28/2020
2NDC:74198-002-02100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/28/2020
3NDC:74198-002-03250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/28/2020
4NDC:74198-002-04500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/28/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/28/2020
Labeler - ALA MEDICAL GROUP PTY LTD (746915311)
Establishment
NameAddressID/FEIBusiness Operations
Henan Bangruite Industry Co., Ltd525663153manufacture(74198-002)

Revised: 3/2020
Document Id: 208dd862-d0ad-4b6b-9c76-04d2d611f6d6
Set id: 0859ba97-f9df-41a9-b490-364f56491cab
Version: 1
Effective Time: 20200327
 
ALA MEDICAL GROUP PTY LTD