Label: THAILUV- alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 78101-001-01, 78101-001-02, 78101-001-03, 78101-001-04, view more78101-001-05 - Packager: THAILUV 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 20, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Uses
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Warnings
For external use only.
When using this product:
• Keep out of eyes .ln case of accidental contact, flush eyes thouroughly with water for 15 m1nutes.
• Advoid contact with broker skin or if you have allergies to any ing redientsStop use and consult a doctor if skin irritation occurs
Keep out of reach of children
- In case of accidental ingestion drink plenty of water and seek medical help or contact Poison Control Center immediately
- External use only
FLAMMABLE: Keep out of heat
- KEEP OUT OF REACH OF CHILDREN
- Directions
- SPL UNCLASSIFIED SECTION
- Inactive Ingredients
- Product Label
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INGREDIENTS AND APPEARANCE
THAILUV
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:78101-001 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 CARBOMER 940 (UNII: 4Q93RCW27E) TRIETHANOLAMINE HYDRIODIDE (UNII: DT98IT03JK) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:78101-001-01 125 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/20/2020 2 NDC:78101-001-02 250 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/20/2020 3 NDC:78101-001-03 500 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/20/2020 4 NDC:78101-001-04 1000 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/20/2020 5 NDC:78101-001-05 3785 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/20/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 05/20/2020 Labeler - THAILUV LLC (009728757)
