Label: HAND SANITIZER- hypochlorous acid gel
-
Contains inactivated NDC Code(s)
NDC Code(s): 78391-002-01 - Packager: Kepter Mexico S.A de C.V
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Drug Label Information
Updated May 30, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredient(s)
- Purpose
- Use
- Warnings
- Do not use
-
WHEN USING
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 doctor: If irritation, rash or redness occurs. These may be signs of serious condition.
Keep out of reach of children: If swallowed, get medical help or contact a Poison Control Center right away.
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
- Inactive ingredients
- Package Label - Principal Display Panel
-
INGREDIENTS AND APPEARANCE
HAND SANITIZER
hypochlorous acid gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:78391-002 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYPOCHLOROUS ACID (UNII: 712K4CDC10) (HYPOCHLOROUS ACID - UNII:712K4CDC10) HYPOCHLOROUS ACID 0.0005 mg in 100 mL Inactive Ingredients Ingredient Name Strength EDETIC ACID (UNII: 9G34HU7RV0) 0.05 mL in 100 mL TROLAMINE (UNII: 9O3K93S3TK) 1.2 mL in 100 mL CARBOMER 940 (UNII: 4Q93RCW27E) 1 mL in 100 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:78391-002-01 250 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/30/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 05/30/2020 Labeler - Kepter Mexico S.A de C.V (812889284) Establishment Name Address ID/FEI Business Operations Kepter Mexico S.A de C.V 812889284 manufacture(78391-002)