PRIMEAUTY INSTANT HAND SANITIZER- ethyl alcohol gel

Primeauty Instant Hand Sanitizer by

Drug Labeling and Warnings

Primeauty Instant Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Huizhou Duomei Daily Necessites Co.,Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Ethyl alcohol 75% v/v

Purpose

Antiseptic

Use

• For hand washing to decrease bacteria on the skin.
• Recommended for repeated use.

Warnings

For external use only.

Flammable, keep away from heat and flame.

Do not use

Do not use in the eyes, in case of contact, rinse eyes thoroughly with water.

Do not use on children less than 2 months of age.

Stop use and ask a doctor if

• Irritation and redness develop and persist for more than 72 hours.
• Swallowed, get medical help or contact a posion control center right away.

Keep out of reach of children

Children must be supervised in use of this product.

Directions

• Put enough product in your palm to cover hands and rub hands together until dry.
• Children under 6 years of age should be supervised when using this product.

Other information

• Store below 110F （43C）
• May discolor certian fabrics or surfaces.

Inactive ingredients

Aqua(Water),

Glycerin,

Carbomer,

Triethanolamine,

Fragrance,

Aloe,

Tocopheryl Acetate (Vitamin E)

Label

INGREDIENTS AND APPEARANCE

PRIMEAUTY INSTANT HAND SANITIZER 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75186-007
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
GLYCERIN (UNII: PDC6A3C0OX)
TROLAMINE (UNII: 9O3K93S3TK)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
WATER (UNII: 059QF0KO0R)
ALOE (UNII: V5VD430YW9)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75186-007-01	10 mL in 1 TUBE; Type 0: Not a Combination Product	08/28/2020
2	NDC: 75186-007-02	20 mL in 1 TUBE; Type 0: Not a Combination Product	08/28/2020
3	NDC: 75186-007-03	30 mL in 1 TUBE; Type 0: Not a Combination Product	08/28/2020
4	NDC: 75186-007-04	50 mL in 1 TUBE; Type 0: Not a Combination Product	08/28/2020
5	NDC: 75186-007-05	60 mL in 1 TUBE; Type 0: Not a Combination Product	08/28/2020
6	NDC: 75186-007-06	80 mL in 1 TUBE; Type 0: Not a Combination Product	08/28/2020
7	NDC: 75186-007-07	100 mL in 1 TUBE; Type 0: Not a Combination Product	08/28/2020
8	NDC: 75186-007-08	150 mL in 1 TUBE; Type 0: Not a Combination Product	08/28/2020
9	NDC: 75186-007-09	200 mL in 1 TUBE; Type 0: Not a Combination Product	08/28/2020
10	NDC: 75186-007-10	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/28/2020
11	NDC: 75186-007-11	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/28/2020
12	NDC: 75186-007-12	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/28/2020
13	NDC: 75186-007-13	80 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/28/2020
14	NDC: 75186-007-14	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/28/2020
15	NDC: 75186-007-15	150 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/28/2020
16	NDC: 75186-007-16	200 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/28/2020
17	NDC: 75186-007-17	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/28/2020
18	NDC: 75186-007-18	240 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	08/28/2020
19	NDC: 75186-007-19	250 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	08/28/2020
20	NDC: 75186-007-20	300 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	08/28/2020
21	NDC: 75186-007-21	350 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	08/28/2020
22	NDC: 75186-007-22	400 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	08/28/2020
23	NDC: 75186-007-23	500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	08/28/2020
24	NDC: 75186-007-24	1000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	08/28/2020
25	NDC: 75186-007-25	1000 mL in 1 DRUM; Type 0: Not a Combination Product	08/28/2020
26	NDC: 75186-007-26	2000 mL in 1 DRUM; Type 0: Not a Combination Product	08/28/2020
27	NDC: 75186-007-27	4000 mL in 1 DRUM; Type 0: Not a Combination Product	08/28/2020
28	NDC: 75186-007-28	5000 mL in 1 DRUM; Type 0: Not a Combination Product	08/28/2020
29	NDC: 75186-007-29	10000 mL in 1 DRUM; Type 0: Not a Combination Product	08/28/2020
30	NDC: 75186-007-30	15000 mL in 1 DRUM; Type 0: Not a Combination Product	08/28/2020
31	NDC: 75186-007-31	20000 mL in 1 DRUM; Type 0: Not a Combination Product	08/28/2020
32	NDC: 75186-007-32	25000 mL in 1 DRUM; Type 0: Not a Combination Product	08/28/2020
33	NDC: 75186-007-33	50000 mL in 1 DRUM; Type 0: Not a Combination Product	08/28/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	08/28/2020

Labeler - Huizhou Duomei Daily Necessites Co.,Ltd (554530153)

Establishment
Name	Address	ID/FEI	Business Operations
Huizhou Duomei Daily Necessites Co.,Ltd		554530153	manufacture(75186-007)