optisafe antiseptic hand sanitizer

optisafe antiseptic hand sanitizer
SPL v1
SPL
SPL Set ID 0b19d929-e1a4-4722-9a1a-9c8eafcf867e
Route
topical
Published
Effective Date 2020-05-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
alcohol (70 mL)
Inactive Ingredients
aloe vera leaf carbomer homopolymer type b (allyl sucrose crosslinked) glycerin propylene glycol .alpha.-tocopherol acetate trolamine

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2020-05-05

Purpose

Antiseptic

Description

Ethyl alcohol 70% v/v


Medication Information

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 • on broken skin

When using this product

• do not get into eyes. In case of contact, rinse eyes thoroughly with water.

• do not inhale or ingest.

Stop use and ask a doctor if 

• irritation and redness develop • condition persists for more than 72 hours

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

Antiseptic

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

aloe vera (Aloe barbadensis) leaf juice, carbomer 934, fragrance, glycerin, propylene glycol, tocopherol acetate (vitamin E), triethanolamine

Description

Ethyl alcohol 70% v/v

Section 42229-5

Microgen® 

Redefining Hygiene...

Manufactured by: Babu Ram Om Prakash

(A Unit of Microgen Hygiene Pvt. Ltd.)

Trilokpur Road, Village-Ogli, Kala Amb, Himachal Pradesh, India, 173 030

HO: 614, Midas, Sahar Plaza, Andheri(E), Mumbai, India, 400 059. Website: www.microgenindia.co

COUNTRY OF ORIGIN: INDIA

Section 50565-1

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

Section 53413-1

Questions?  +1-855-494-3767

You may also report serious side effects to this phone number. Mon-Fri 9.00 AM - 5.00 PM

Packaging

Drug Facts

Active Ingredient

Ethyl alcohol 70% v/v


Structured Label Content

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 • on broken skin

When using this product

• do not get into eyes. In case of contact, rinse eyes thoroughly with water.

• do not inhale or ingest.

Stop use and ask a doctor if 

• irritation and redness develop • condition persists for more than 72 hours

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

Antiseptic

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 (Other information)

• store between 15-30°C (59-86°F)

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

Inactive Ingredients (Inactive ingredients)

aloe vera (Aloe barbadensis) leaf juice, carbomer 934, fragrance, glycerin, propylene glycol, tocopherol acetate (vitamin E), triethanolamine

Section 42229-5 (42229-5)

Microgen® 

Redefining Hygiene...

Manufactured by: Babu Ram Om Prakash

(A Unit of Microgen Hygiene Pvt. Ltd.)

Trilokpur Road, Village-Ogli, Kala Amb, Himachal Pradesh, India, 173 030

HO: 614, Midas, Sahar Plaza, Andheri(E), Mumbai, India, 400 059. Website: www.microgenindia.co

COUNTRY OF ORIGIN: INDIA

Section 50565-1 (50565-1)

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

Section 53413-1 (53413-1)

Questions?  +1-855-494-3767

You may also report serious side effects to this phone number. Mon-Fri 9.00 AM - 5.00 PM

Packaging

Drug Facts

Active Ingredient (Active ingredient)

Ethyl alcohol 70% v/v


Advanced Ingredient Data


Raw Label Data

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