WOLKE HAND SANITIZER- alcohol gel

Wolke Hand Sanitizer by

Drug Labeling and Warnings

Wolke Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Hidro Soluciones Integrales, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

Alcohol 70% v/v

Purpose

Antiseptic

Uses

To decrease bacteria on the skin when water, soap & towel are not available - Recommended for repeated use.

Warnings

- For external use only.

Flammable - Keep away from fire or flame.

When using this product

keep out of eyes. In case of contact with eyes, rinse thoroughly with water. 

Do not use 

on broken or irritated skin.

Stop use and ask a doctor if

irritation or redness develop and last more than 72 hours.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

- Apply enough product to wet hands. Rub hands together until dry. Supervise children in use of this product.

Other information

• Do not store above 105 °F (40 °C).
• May discolor certain wood surfaces.

Inactive Ingredients:

Purified water, carbomer, triethanolamine, glycerin.

Package Labeling: 250ml

Package Labeling: 500ml

Package Labeling: 900ml

INGREDIENTS AND APPEARANCE

WOLKE HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78207-000
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
WATER (UNII: 059QF0KO0R)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
TROLAMINE (UNII: 9O3K93S3TK)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78207-000-01	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/25/2020
2	NDC: 78207-000-02	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/25/2020
3	NDC: 78207-000-03	900 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/25/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	06/25/2020

Labeler - Hidro Soluciones Integrales, S.A. de C.V. (951577999)