100% PURE HAND SANITIZER HYDRATING- ethyl alcohol gel

100% Pure Hand Sanitizer by

Drug Labeling and Warnings

100% Pure Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Purity Cosmetics, Our Babylon LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Ethyl Alcohol 62%

Purpose

Antiseptic

Uses

For cleaning hands when water is not available to help reduce bacteria on the skin. Recommended for repeated use.

Warnings:

• ​For external use only.

STORAGE AND HANDLING

• Flammable, keep away from fire, sparks, and sources of ignition.
• Do not store above 104°F/40°C.

WHEN USING

• When using this product keep out of eyes. In case of contact with eyes, flush thoroughly with water.

KEEP OUT OF REACH OF CHILDREN

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

OTHER SAFETY INFORMATION

• Avoid contact with broken skin.

STOP USE

• Stop use and ask a doctor if irritation and redness develop and persist for more than 72 hours.

Directions:

Dispense directly on hands and rub in thoroughly. For children under 6, use adult supervision. Not recommended for infants.

Other Ingredients:

Aloe Barbadensis (Aloe Vera) Leaf Juice*, Glycerin, Hydroxypropyl Guar, Citric Acid, Aqua (Water) *Organic Ingredient

Questions or Comments?

Call 1.415.814.9788 or visit www.100PercentPure.com

PRINCIPAL DISPLAY PANEL

100% Pure Hand Sanitizer Hydrating Gel

Product NDC: 52667-011

INGREDIENTS AND APPEARANCE

100% PURE HAND SANITIZER  HYDRATING
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52667-011
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)
GUARAPROLOSE (1300 MPA.S AT 1%) (UNII: 1530WMS90S)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52667-011-01	50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/03/2020
2	NDC: 52667-011-02	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/03/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	08/03/2020

Labeler - Purity Cosmetics (055795259)

Registrant - Our Babylon LLC (105266218)

Establishment
Name	Address	ID/FEI	Business Operations
Our Babylon LLC		105266218	manufacture(52667-011)