HAND SANITIZER- ethyl alcohol gel

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Anhui Oasis Disinfection Products Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Ethyl Alcohol 75%

Purpose

Antimicrobial

Use

Hand sanitizer to help reduce bacteria on the hands
To help decrease bacteria on the skin when water, soap and towel are not available

WARNINGS

Flammable. Keep away from fire or flame. For external use only, not on face
■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 imitation or rash appears and lasts

■Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away
1 If signs of rash occur, discontinue use and seek medical advice
■Keep container tightly closed

Directions

■Apply small amount onto your palm, not on open wound

■Rub all parts of hands until dry without rinse
Children under 6 years of age should be supervised during use
Other information
Sore below 86°F (30°C)
1 May discolor certain fabrics or surfaces
■Use within 12 months after open

Inactive ingredients

Aqua, Glycerol, Aloe Barbadensis Extract, Tocopheryl Acetate (Vitamin E), Carbomer, Triethanolamine

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52985-901
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 HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
TROLAMINE (UNII: 9O3K93S3TK)
GLYCERIN (UNII: PDC6A3C0OX)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52985-901-01	150 in 1 BOX	06/18/2020
1		30 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 52985-901-02	120 in 1 BOX	06/18/2020
2		50 mL in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 52985-901-03	100 in 1 BOX	06/18/2020
3		60 mL in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC: 52985-901-04	100 in 1 BOX	06/18/2020
4		100 mL in 1 BOTTLE; Type 0: Not a Combination Product
5	NDC: 52985-901-05	64 in 1 BOX	06/18/2020
5		200 mL in 1 BOTTLE; Type 0: Not a Combination Product
6	NDC: 52985-901-06	30 in 1 BOX	06/18/2020
6		236 mL in 1 BOTTLE; Type 0: Not a Combination Product
7	NDC: 52985-901-07	28 in 1 BOX	06/18/2020
7		300 mL in 1 BOTTLE; Type 0: Not a Combination Product
8	NDC: 52985-901-08	24 in 1 BOX	06/18/2020
8		500 mL in 1 BOTTLE; Type 0: Not a Combination Product
9	NDC: 52985-901-09	12 in 1 BOX	06/18/2020
9		1000 mL in 1 BOTTLE; Type 0: Not a Combination Product
10	NDC: 52985-901-10	4 in 1 BOX	06/18/2020
10		3785 mL in 1 BOTTLE; Type 0: Not a Combination Product
11	NDC: 52985-901-11	500 in 1 BOX	06/18/2020
11		10 mL in 1 BOTTLE; Type 0: Not a Combination Product
12	NDC: 52985-901-12	500 in 1 BOX	06/18/2020
12		15 mL in 1 BOTTLE; Type 0: Not a Combination Product
13	NDC: 52985-901-13	400 in 1 BOX	06/18/2020
13		25 mL in 1 BOTTLE; Type 0: Not a Combination Product
14	NDC: 52985-901-14	150 in 1 BOX	06/18/2020
14		35 mL in 1 BOTTLE; Type 0: Not a Combination Product
15	NDC: 52985-901-15	120 in 1 BOX	06/18/2020
15		55 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	06/18/2020

Labeler - Anhui Oasis Disinfection Products Co., Ltd (529664312)

Establishment
Name	Address	ID/FEI	Business Operations
Anhui Oasis Disinfection Products Co., Ltd		529664312	manufacture(52985-901)