Label: ACCURATE LABS ANTISEPTIC HAND SANITIZER- ethyl alcohol liquid
-
NDC Code(s):
78434-110-02,
78434-110-04,
78434-110-08,
78434-110-16, view more78434-110-32, 78434-110-64, 78434-110-70, 78434-110-75, 78434-110-80, 78434-110-85, 78434-110-90
- Packager: Accurate Labs, LLC
- Category: HUMAN OTC DRUG LABEL
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 October 7, 2021
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient
- Purpose
- Uses
-
Warnings
Flammable, keep away from fire/flame
For external use onlyDo not use • in children less than 2 months of age • on open skin wounds
When using this product • do not get into eyes. In case of contact, rinse eyes thoroughly with water
Stop use and ask a doctor if
• irritation and redness develop
• condition persists for more than 72 hours - Directions
- Other information
- Inactive ingredients
- Questions?
- SPL UNCLASSIFIED SECTION
- Packaging
-
INGREDIENTS AND APPEARANCE
ACCURATE LABS ANTISEPTIC HAND SANITIZER
ethyl alcohol liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:78434-110 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 80 L in 100 L Inactive Ingredients Ingredient Name Strength LIMONENE, (+)- (UNII: GFD7C86Q1W) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:78434-110-02 0.059 L in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 06/01/2020 06/30/2025 2 NDC:78434-110-04 0.118 L in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 06/01/2020 06/30/2025 3 NDC:78434-110-08 0.236 L in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 06/01/2020 06/30/2025 4 NDC:78434-110-16 0.473 L in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 06/01/2020 06/30/2025 5 NDC:78434-110-32 0.946 L in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 06/01/2020 06/30/2025 6 NDC:78434-110-64 1.89 L in 1 BOTTLE; Type 0: Not a Combination Product 06/01/2020 06/30/2025 7 NDC:78434-110-70 3.79 L in 1 BOTTLE; Type 0: Not a Combination Product 06/01/2020 06/30/2025 8 NDC:78434-110-75 9.46 L in 1 CONTAINER; Type 0: Not a Combination Product 06/01/2020 06/30/2025 9 NDC:78434-110-80 18.93 L in 1 CONTAINER; Type 0: Not a Combination Product 06/01/2020 06/30/2025 10 NDC:78434-110-85 208.2 L in 1 CONTAINER; Type 0: Not a Combination Product 06/01/2020 06/30/2025 11 NDC:78434-110-90 1211.3 L in 1 CONTAINER; Type 0: Not a Combination Product 06/01/2020 06/30/2025 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 06/01/2020 06/30/2025 Labeler - Accurate Labs, LLC (113427259) Establishment Name Address ID/FEI Business Operations Accurate Labs, LLC 113427259 manufacture(78434-110)