PALMIST ANTISEPTIC HAND SANITIZER- ethyl alcohol gel

PALMIST ANTISEPTIC HAND SANITIZER by

Drug Labeling and Warnings

PALMIST ANTISEPTIC HAND SANITIZER by is a Otc medication manufactured, distributed, or labeled by POCKET INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Ethyl alcohol 70% v/v

Purpose

Antiseptic

Uses

hand sanitizer to decrease bacteria on the skin  recommended for repeated use  for use when soap and water are not available

Warnings

Flammable, keep away from fire/flame
For external use only

Do not use  in children less than 2 months of age on open skin wounds

When using this product  do not get into eyes. In case of contact, rinse eyes thoroughly with water

Stop use and ask a doctor if  irritation and redness develop  condition persists for more than 72 hours

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

 wet hands thoroughly with product and allow to dry without wiping supervise children under 6 years of age when using this product to avoid swallowing

Other information

store between 15-30°C (59-86°F)  avoid freezing and excessive heat above 40°C (104°F)

Inactive ingredients

benzalkonium chloride, carbomer, holy basil (Ocimum tenuiflorum), lemon (Citrus medica limonum) oil, neem (Azadirachta indica) leaf extract, triethanolamine, water

Questions?

+1-412-999-4501

You may also report serious side effects to this phone number. Mon-Fri 9:00 AM - 5:00 PM

SPL UNCLASSIFIED SECTION

Distributed by: LSM DISTRIBUTION LLC.
312 WEST 7th AVENUE, WEST HOMESTEAD, PA 15120

MADE IN INDIA

Ismdistributionllc@gmail.com

www.palmist.net

Packaging

INGREDIENTS AND APPEARANCE

PALMIST ANTISEPTIC HAND SANITIZER 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80636-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
HOLY BASIL LEAF (UNII: SCJ765569P)
LEMON OIL (UNII: I9GRO824LL)
AZADIRACHTA INDICA LEAF (UNII: HKY915780T)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80636-101-01	30 in 1 BOX	09/25/2020
1		1 mL in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 80636-101-20	200 in 1 BAG	09/25/2020
2		1 mL in 1 PACKET; Type 0: Not a Combination Product
3	NDC: 80636-101-45	30 in 1 BOX	09/25/2020
3		1.5 mL in 1 PACKET; Type 0: Not a Combination Product
4	NDC: 80636-101-30	200 in 1 BAG	09/25/2020
4		1.5 mL in 1 PACKET; Type 0: Not a Combination Product
5	NDC: 80636-101-60	30 in 1 BOX	09/25/2020
5		2 mL in 1 PACKET; Type 0: Not a Combination Product
6	NDC: 80636-101-40	200 in 1 BAG	09/25/2020
6		2 mL in 1 PACKET; 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	part333A	09/25/2020

Labeler - POCKET INC (857979919)

Establishment
Name	Address	ID/FEI	Business Operations
POCKET INC		857979919	manufacture(80636-101)