Hydro by HYDRO GLOBAL INC / Aloe Laboratories, Inc / Chemical Solutions de México, S.A. de C.V. HYDRO- alcohol gel

Hydro by

Drug Labeling and Warnings

Hydro by is a Otc medication manufactured, distributed, or labeled by HYDRO GLOBAL INC, Aloe Laboratories, Inc, Chemical Solutions de México, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Ethyl Alcohol 70% v/v ......................Antimicrobial

Purpose

Antimicrobial, 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)

Inactive ingredients

Water, Triethanolamine, Carbomer, Aloe Vera Extract, Phenoxethynol

Package Label - Principal Display Panel

HYDRO Hand Sanitizer Gel with Aloe

8.5 OZ (250 mL)

INGREDIENTS AND APPEARANCE

HYDRO 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77994-100
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
PHENOXYETHANOL (UNII: HIE492ZZ3T)	0.0003 mL  in 1 mL
ALOE VERA LEAF (UNII: ZY81Z83H0X)	0.001 mL  in 1 mL
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)	0.002 mL  in 1 mL
WATER (UNII: 059QF0KO0R)	0.4 mL  in 1 mL
TROLAMINE (UNII: 9O3K93S3TK)	0.0025 mCi  in 1 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77994-100-01	250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/01/2020

Labeler - HYDRO GLOBAL INC (117523372)

Establishment
Name	Address	ID/FEI	Business Operations
Aloe Laboratories, Inc		606458024	repack(77994-100)

Establishment
Name	Address	ID/FEI	Business Operations
Chemical Solutions de México, S.A. de C.V.		813291820	manufacture(77994-100)