Label: KERMA HAND SANITIZER- ethyl alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 71358-018-01 - Packager: MCCORD RESEARCH
- 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 January 25, 2022
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- Official Label (Printer Friendly)
- Active lngredient
- Purpose
- Uses
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Warnings
For external use only. Flammable. Keep away from heat or flame
Do not use
• in children less than 2 months of age
• on open skin wounds
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. If swallowed, get medical help or contact a Poison Control Center right away. - Directions
- Other information
- Inactive Ingredients
- KEEP OUT OF REACH OF CHILDREN
- product Label
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INGREDIENTS AND APPEARANCE
KERMA HAND SANITIZER
ethyl alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71358-018 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 620 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F) CHLORPHENESIN (UNII: I670DAL4SZ) AMINOMETHYLPROPANOL (UNII: LU49E6626Q) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71358-018-01 237 mL in 1 BOTTLE; Type 0: Not a Combination Product 04/03/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 04/03/2020 Labeler - MCCORD RESEARCH (010011284) Establishment Name Address ID/FEI Business Operations Wasatch Product Development, LLC 962452533 manufacture(71358-018)