SOCAL FARMHOUSE GEL HAND SANITIZER- isopropyl alcohol gel

SoCal Farmhouse Gel Hand Sanitizer by

Drug Labeling and Warnings

SoCal Farmhouse Gel Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Blue Angel Hot Tubs. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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)

Isopropyl Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

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

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

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Place enough product on hands to cover all surfaces. Rub hands together until dry.
• Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

• Store between 15-30C (59-86F)
• Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

glycerin, propylene glycol USP, TRIETHANOLAMINE, purified water USP, carbomer, fd&c red 3, yellow 5, blue 1

Package Label - Principal Display Panel

​120 ml NDC: 77300-101-01

INGREDIENTS AND APPEARANCE

SOCAL FARMHOUSE GEL HAND SANITIZER 
isopropyl alcohol gel

Product 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)