TOUCH OF SHEA HAND SANITIZER- ethyl alcohol gel

Touch of Shea Hand Sanitizer by

Drug Labeling and Warnings

Touch of Shea Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Homemade Shea LLC, Homemade Shea. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Flammable. Keep away from fire or flame. For external use only.

Warning: Flammable. Keep away from fire or flame. For external use only.

Ethyl Alcohol 70%

Ethyl Alcohol 70% Purpose: Antiseptic

Do not use in eyes. In case of contact with eyes, rinse with water.

Do not use in eyes. In case of contact with eyes, rinse with water

When using this product

Do not use in eyes. In case of contact with eyes, rinse with water.

irritation and redness develop and persist.

ask doctor if irritation and redness develop and persist

If swallowed, get medical help promptly.

If swallowed get medical help promptly

Inactive Ingredients

WATER

ISOPROPYL ALCOHOL

GLYCERIN

POLYACRYLIC ACID

PROPYLENE GLYCOL

.ALPHA.-TOCOPHEROL ACETATE

ALOE VERA LEAF

Other Information - Store under 105°F

Store Under 105ºF

Uses

For handwashing to decrease bacteria on the skin

Wet hands thoroughly with product and allow to dry without wiping.

Wet hands thoroughly with product and allow to dry without wiping.

Purpose

Antiseptic

2oz NDC:

78401-444-02

INGREDIENTS AND APPEARANCE

TOUCH OF SHEA HAND SANITIZER 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78401-444(NDC:66902-343)
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.7 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F)
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78401-444-02	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/20/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/10/2020

Labeler - Homemade Shea LLC (097200813)

Establishment
Name	Address	ID/FEI	Business Operations
Homemade Shea		097200813	repack(78401-444)