HAND SANITIZER(WITH FRAGRANT)- alcohol gel

United States - English - NLM (National Library of Medicine)

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Active ingredient:
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)
Available from:
Zhongrong Technology Corporation Ltd.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Antibacterial, Hand Sanitizer To help eliminate bacteria on the skin that may cause disease and moisturize skin. - in children less than 2 months of age - on open skin wounds Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Authorization status:
OTC monograph not final
Authorization number:
81191-002-01, 81191-002-02, 81191-002-03, 81191-002-04, 81191-002-05, 81191-002-06, 81191-002-07, 81191-002-08, 81191-002-09, 81191-002-10, 81191-002-11, 81191-002-12, 81191-002-13, 81191-002-14, 81191-002-15, 81191-002-16, 81191-002-17, 81191-002-18, 81191-002-19, 81191-002-20, 81191-002-21, 81191-002-22, 81191-002-23, 81191-002-24

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HAND SANITIZER(WITH FRAGRANT)- alcohol gel

Zhongrong Technology Corporation Ltd.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they

comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Hand sanitizer

Active Ingredient(s)

Ethyl Alcohol 75% v/v. Purpose: Antibacterial

Purpos e

Antibacterial, Hand Sanitizer

Us e

To help eliminate bacteria on the skin that may cause disease and moisturize skin.

Warnings

For external use only. Flammable. Keep away from heat and flame. Avoid contact with eyes and broken

skin. Keep out of reach of children.

Do not use

in children less than 2 months of age

on open skin wounds

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 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.

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)

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

Inactive ingredients

purified water, Carbopol,Propylene Glycol, Trolamine, Fragrance.

Package Label - Principal Display Panel

500 mL NDC: 81191-002-12

HAND SANITIZER(WITH FRAGRANT)

alcohol gel

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:8 119 1-0 0 2

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ALCO HO L (UNII: 3K9 9 58 V9 0 M) (ALCOHOL - UNII:3K9 9 58 V9 0 M)

ALCOHOL

75 mL in 10 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

TRO LAMINE (UNII: 9 O3K9 3S3TK)

FRAGRANCE FLO RAL O RC0 9 0 2 2 3 6 (UNII: R6 6 Z4YW3X0 )

CARBO MER HO MO PO LYMER, UNSPECIFIED TYPE (UNII: 0 A5MM30 7FC)

PRO PYLENE GLYCO L 1,2 -DISTEARATE (UNII: T6 5PN3O37H)

WATER (UNII: 0 59 QF0 KO0 R)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:8 119 1-0 0 2-

30 mL in 1 BOTTLE, SPRAY; Type 0 : No t a Co mbinatio n

Pro duc t

11/26 /20 20

2

NDC:8 119 1-0 0 2-

50 mL in 1 BOTTLE, SPRAY; Type 0 : No t a Co mbinatio n

Pro duc t

11/26 /20 20

3

NDC:8 119 1-0 0 2-

6 0 mL in 1 BOTTLE, SPRAY; Type 0 : No t a Co mbinatio n

Pro duc t

11/26 /20 20

4

NDC:8 119 1-0 0 2-

8 0 mL in 1 BOTTLE, SPRAY; Type 0 : No t a Co mbinatio n

Pro duc t

11/26 /20 20

5

NDC:8 119 1-0 0 2-

10 0 mL in 1 BOTTLE, SPRAY; Type 0 : No t a Co mbinatio n

Pro duc t

11/26 /20 20

6

NDC:8 119 1-0 0 2-

150 mL in 1 BOTTLE, SPRAY; Type 0 : No t a Co mbinatio n

Pro duc t

11/26 /20 20

7

NDC:8 119 1-0 0 2-

20 0 mL in 1 BOTTLE, SPRAY; Type 0 : No t a Co mbinatio n

Pro duc t

11/26 /20 20

8

NDC:8 119 1-0 0 2-

236 mL in 1 BOTTLE, SPRAY; Type 0 : No t a Co mbinatio n

Pro duc t

11/26 /20 20

9

NDC:8 119 1-0 0 2-

240 mL in 1 BOTTLE, SPRAY; Type 0 : No t a Co mbinatio n

Pro duc t

11/26 /20 20

10

NDC:8 119 1-0 0 2-

250 mL in 1 BOTTLE, SPRAY; Type 0 : No t a Co mbinatio n

Pro duc t

11/26 /20 20

11

NDC:8 119 1-0 0 2-

30 0 mL in 1 BOTTLE, SPRAY; Type 0 : No t a Co mbinatio n

Pro duc t

11/26 /20 20

12

NDC:8 119 1-0 0 2-

50 0 mL in 1 BOTTLE, SPRAY; Type 0 : No t a Co mbinatio n

Pro duc t

11/26 /20 20

13

NDC:8 119 1-0 0 2-

6 0 0 mL in 1 BOTTLE, SPRAY; Type 0 : No t a Co mbinatio n

Pro duc t

11/26 /20 20

14

NDC:8 119 1-0 0 2-

8 0 0 mL in 1 BOTTLE, SPRAY; Type 0 : No t a Co mbinatio n

Pro duc t

11/26 /20 20

15

NDC:8 119 1-0 0 2-

9 0 0 mL in 1 BOTTLE, SPRAY; Type 0 : No t a Co mbinatio n

Pro duc t

11/26 /20 20

16

NDC:8 119 1-0 0 2-

10 0 0 mL in 1 BOTTLE, SPRAY; Type 0 : No t a Co mbinatio n

Pro duc t

11/26 /20 20

17

NDC:8 119 1-0 0 2-

20 0 0 mL in 1 BOTTLE, SPRAY; Type 0 : No t a Co mbinatio n

Pro duc t

11/26 /20 20

18

NDC:8 119 1-0 0 2-

378 0 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

11/26 /20 20

19

NDC:8 119 1-0 0 2-

50 0 0 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

11/26 /20 20

2 0

NDC:8 119 1-0 0 2-

10 0 0 0 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

11/26 /20 20

2 1

NDC:8 119 1-0 0 2-

10 0 0 0 0 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

11/26 /20 20

2 2

NDC:8 119 1-0 0 2-

20 0 0 0 0 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

11/26 /20 20

2 3

NDC:8 119 1-0 0 2-

10 0 0 0 0 0 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n

Pro duc t

11/26 /20 20

2 4

NDC:8 119 1-0 0 2-

250 0 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

11/26 /20 20

Zhongrong Technology Corporation Ltd.

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt333A

11/26 /20 20

Labeler -

Zhongrong T echnology Corporation Ltd. (529575698)

Registrant -

Zhongrong T echnology Corporation Ltd. (529575698)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Zho ngro ng Techno lo gy Co rpo ratio n Ltd.

529 5756 9 8

manufacture(8 119 1-0 0 2) , label(8 119 1-0 0 2)

Revised: 12/2020

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