SOLE WIPE- 70% ethanal alcohol gel

Sole Wipe by

Drug Labeling and Warnings

Sole Wipe by is a Otc medication manufactured, distributed, or labeled by Soul Wipe, Inc., Prime Matter Labs West, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

STATEMENT OF IDENTITY

Hand Sanitizer Hand Wipe

ACTIVE INGREDIENT

Ethyl Alcohol 70% v/v

PURPOSE

Antiseptic

INDICATIONS & USAGE

Hand Sanitizer to help reduce bacteria on the skin

WARNINGS

Flammable. Keep away from sources of heat, fire or flame

For external use only

When using this product, do not use in or near the eyes.

In case of contact, rinse eyes thoroughly with water

Stop use and ask a doctor if irritation or redness develops and lasts

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

WHEN USING

Avoid contact with eyes. If so flush with plenty of water for 15 minutes immediately

ASK DOCTOR

Stop use and ask a doctor if irritation develops ans lasts.

KEEP OUT OF REACH OF CHILDREN

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

Directions

Use one wipe per pair of hands to avoid cross contamination

Seal after each use

Avoid contact with eyes. If so, flush with prenty of water for 15min immediately

Supervise children under 6 years of age when using this product to avoid swallowing

INACTIVE INGREDIENT

Water (aqua), Glyserin, Aloe Barbadensis leaf juice, Calendula Offincinalls (Marigold) flower extract, Camella Sinensis (white tea) leaf extract, Citrus Aurantium (Bergamont) Oil, Matricaria Recultita (Chamomile) flower extract, PogostemonCablin (Patchouli) oil, rock chrystals

STORAGE AND HANDLING

Flammable. Keep away from sources of heat, fire or flame

Seal after each use

Crown Chakra

INGREDIENTS AND APPEARANCE

SOLE WIPE 
70% ethanal alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81813-507
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
BURSERA GRAVEOLENS FRUIT OIL (UNII: R0U10T34I4)	0.1 mL  in 100 mL
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
GLYCERIN (UNII: PDC6A3C0OX)	25 mL  in 100 mL
CHAMOMILE (UNII: FGL3685T2X)	0.005 mL  in 100 mL
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)	0.005 mL  in 100 mL
GREEN TEA LEAF (UNII: W2ZU1RY8B0)	0.005 mL  in 100 mL
ALOE VERA LEAF (UNII: ZY81Z83H0X)	0.005 mL  in 100 mL
WATER (UNII: 059QF0KO0R)
VETIVER OIL (UNII: 9M9P32M01L)	0.1 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81813-507-01	500 mL in 1 JAR; Type 0: Not a Combination Product	05/11/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	05/11/2021

Labeler - Soul Wipe, Inc. (101974567)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Matter Labs West, LLC		118568102	manufacture(81813-507)