Label: AMERIGEL HAND SANITIZER- hand sanitizer gel
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Contains inactivated NDC Code(s)
NDC Code(s): 79417-010-06, 79417-010-16 - Packager: Kova Laboratories, Inc.
- 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 December 1, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient(s)
- Purpose
- Use
- Warnings
- Do not use
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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 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. - STOP USE
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
- Inactive ingredients
- Amerigel Hand Sanitizer 6 oz
- Amerigel Hand Sanitizer 16 oz
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INGREDIENTS AND APPEARANCE
AMERIGEL HAND SANITIZER
hand sanitizer gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79417-010 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 70 L in 100 L Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) 28.397 L in 100 L ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.05 L in 100 L LINALOOL, (+/-)- (UNII: D81QY6I88E) 0.07 L in 100 L CARBOMER 1342 (UNII: 809Y72KV36) 0.27 L in 100 L PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 0.5 L in 100 L PEG-8 DIMETHICONE (UNII: GIA7T764OD) 0.3 L in 100 L TRIISOPROPANOLAMINE (UNII: W9EN9DLM98) 0.41 L in 100 L FD&C BLUE NO. 1 (UNII: H3R47K3TBD) 0.003 L in 100 L Product Characteristics Color blue (Translucent Gel) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79417-010-06 0.177 L in 1 TUBE; Type 0: Not a Combination Product 07/02/2020 2 NDC:79417-010-16 0.473 L in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 12/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 07/02/2020 Labeler - Kova Laboratories, Inc. (193055027) Registrant - Kova Laboratories, Inc. (193055027) Establishment Name Address ID/FEI Business Operations Kova Laboratories, Inc. 193055027 label(79417-010) , manufacture(79417-010)