PHARMA HEALTH- hand sanitizer gel gel

Pharma Health by

Drug Labeling and Warnings

Pharma Health by is a Otc medication manufactured, distributed, or labeled by Pharma Health LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Alcohol 75% v/v. Purpose: Antiseptic

Purpose

Antiseptic, 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

Put enough product in your palm to cover hands and rub hands together briskly until dry.

Children under 6 years of age should be supervised when using products.

Other information

Avoid freezing and excessive heat above 40C (104F)

May discolor certain fabrics or surfaces

Inactive ingredients

carbomer, triethanolamine, water

Package Label - Principal Display Panel

3785 mL NDC: 79040-111-13

INGREDIENTS AND APPEARANCE

PHARMA HEALTH 
hand sanitizer gel gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79040-111
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	75 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER 940 (UNII: 4Q93RCW27E)
CUPRIC BIS(TRIETHANOLAMINE) (UNII: YBM44X0B6H)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79040-111-11	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/23/2020
2	NDC: 79040-111-12	946 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/23/2020
3	NDC: 79040-111-13	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/23/2020
4	NDC: 79040-111-14	40 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/23/2020
5	NDC: 79040-111-15	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/23/2020
6	NDC: 79040-111-16	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/23/2020
7	NDC: 79040-111-17	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/23/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/23/2020

Labeler - Pharma Health LLC (117551722)

Establishment
Name	Address	ID/FEI	Business Operations
Pharma Health LLC		117551722	manufacture(79040-111)