Label: BIONAMICS- ethyl alcohol spray
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Contains inactivated NDC Code(s)
NDC Code(s): 74198-002-01, 74198-002-02, 74198-002-03, 74198-002-04 - Packager: ALA MEDICAL GROUP PTY LTD
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated March 27, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active lngredient
- Purpose
- Uses
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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
- Keep out of re ach of children
- Products Labels
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INGREDIENTS AND APPEARANCE
BIONAMICS
ethyl alcohol sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:74198-002 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 75 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:74198-002-01 50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/28/2020 2 NDC:74198-002-02 100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/28/2020 3 NDC:74198-002-03 250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/28/2020 4 NDC:74198-002-04 500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/28/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 03/28/2020 Labeler - ALA MEDICAL GROUP PTY LTD (746915311) Establishment Name Address ID/FEI Business Operations Henan Bangruite Industry Co., Ltd 525663153 manufacture(74198-002)
