Label: SOCAL FARMHOUSE GEL HAND SANITIZER- isopropyl alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 77300-101-01 - Packager: Blue Angel Hot Tubs
- 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 5, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
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SPL UNCLASSIFIED SECTION
This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.
- 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
- Package Label - Principal Display Panel
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INGREDIENTS AND APPEARANCE
SOCAL FARMHOUSE GEL HAND SANITIZER
isopropyl alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:77300-101 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL 70 mL in 100 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL in 100 mL PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 2 mL in 100 mL WATER (UNII: 059QF0KO0R) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) 0.02 mL in 100 mL CUPRIC BIS(TRIETHANOLAMINE) (UNII: YBM44X0B6H) 3 mL in 100 mL CARBOMER 940 (UNII: 4Q93RCW27E) 0.3 mL in 100 mL FD&C BLUE NO. 1 (UNII: H3R47K3TBD) 0.02 mL in 100 mL FD&C RED NO. 3 (UNII: PN2ZH5LOQY) 0.05 mL in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:77300-101-01 120 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product 04/15/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 04/14/2020 Labeler - Blue Angel Hot Tubs (153641092)