Label: HEALTHY SPIRIT- alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 73745-001-01, 73745-001-02, 73745-001-03 - Packager: K2 HEALTH PRODUCTS LLC
- 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 May 11, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Use
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Warnings
Do not freeze. For external use only.
Do not use
- in children less than 2 months of age
- in ears or mouth
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
- Directions
- Inactive ingredients
- Package Label - Principal Display Panel
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INGREDIENTS AND APPEARANCE
HEALTHY SPIRIT
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73745-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.13 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ISOPROPYL ALCOHOL (UNII: ND2M416302) HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D) GLYCERIN (UNII: PDC6A3C0OX) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) DMDM HYDANTOIN (UNII: BYR0546TOW) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73745-001-01 473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/12/2020 2 NDC:73745-001-02 1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/19/2020 3 NDC:73745-001-03 3000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/19/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 05/12/2020 Labeler - K2 HEALTH PRODUCTS LLC (800616612)
