Archstone Essentials by Zhejiang Beta Industry And Trade Co., Ltd. Archstone Essentials

Archstone Essentials by

Drug Labeling and Warnings

Archstone Essentials by is a Otc medication manufactured, distributed, or labeled by Zhejiang Beta Industry And Trade Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ARCHSTONE ESSENTIALS- alcohol gel 
Zhejiang Beta Industry And Trade Co., 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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Archstone Essentials

Active Ingredient(s)

Ethyl alcohol 75%

Purpose

Antimicrobial

Use

to decrease bacteria on the skin that couldcause disease
recommended for repeated use

Warnings

For external use only-hands Flammable. Keep away from heat and flame.

Do not use

/

keep out of eyesIn case of contact with eyes, flush thoroughly with water
avoid contact with broken skin
do not inhale or ingest

Stop use and ask a doctor if skin irritation develops

Keep out of reach of children. If swallowedlet medical help or contact a Poison Control centerright away

Directions

wet hands thoroughly withproduct and allow to dry without wiping
for children under 6, use only under adultsupervision
not recommended for infants

do not store above 105°F
may discolor some fabrics
harmful towood finishes and plastics

Inactive ingredients

water, glycerin, carbomer,triethanolamine

Package Label - Principal Display Panel

ARCHSTONE ESSENTIALS 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77060-023
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
WATER (UNII: 059QF0KO0R)
TROLAMINE (UNII: 9O3K93S3TK)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77060-023-04	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
2	NDC: 77060-023-06	240 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
3	NDC: 77060-023-08	300 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
4	NDC: 77060-023-02	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
5	NDC: 77060-023-09	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
6	NDC: 77060-023-10	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
7	NDC: 77060-023-05	150 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
8	NDC: 77060-023-03	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
9	NDC: 77060-023-07	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
10	NDC: 77060-023-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/30/2020	04/12/2022

Labeler - Zhejiang Beta Industry And Trade Co., Ltd. (411892770)

Registrant - Zhejiang Beta Industry And Trade Co., Ltd. (411892770)

Establishment
Name	Address	ID/FEI	Business Operations
Zhejiang Beta Industry And Trade Co., Ltd.		411892770	manufacture(77060-023)

Revised: 4/2022

Document Id: dc721891-bb1a-5684-e053-2a95a90a294b

34390-5

Set id: a986a00b-2f27-d9e1-e053-2a95a90a174e

Version: 3

Effective Time: 20220412

 

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