NEW HORIZON HAND SANITIZER- alcohol gel

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

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Active ingredient:
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)
Available from:
Sokol and Company
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
to decrease bacteria on the skin
Authorization status:
OTC monograph not final
Authorization number:
81215-000-01

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NEW HORIZON HAND SANITIZER- alcohol gel

Sokol and Company

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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New Horizon Hand Sanitizer

Drug Facts

Active ingredient

Alcohol 70% v/v

Purpose

Antiseptic

Uses

to decrease bacteria on the skin

Warnings

For external use only. Flammable, keep away from fire or flame

When using this product

keep away from eyes. In case of eye contact, rinse eyes with water.

Stop use and ask a doctor

if irritation or redness develop or last more than 72 hours

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

apply liberally to hands to cover all surfaces

rub hands together until dry

supervise children under 6 years old

not recommended for infants

Other information

store between 15-30C (59-86F)

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

Inactive ingredients

glycerin, methylcellulose, purified water

Package Labeling:

NEW HORIZON HAND SANITIZER

alcohol gel

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:8 1215-0 0 0

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

0 .7 mL in 1 mL

Sokol and Company

Inactive Ingredients

Ingredient Name

Stre ng th

GLYCERIN (UNII: PDC6 A3C0 OX)

METHYLCELLULO SE, UNSPECIFIED (UNII: Z9 44H5SN0 H)

WATER (UNII: 0 59 QF0 KO0 R)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:8 1215-0 0 0 -0 1

1.7 mL in 1 POUCH; Type 0 : No t a Co mbinatio n Pro duct

12/0 8 /20 20

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 rt333E

12/0 8 /20 20

Labeler -

Sokol and Company (005122197)

Revised: 12/2020

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