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​lubrima
SPL v1
SPL
SPL Set ID e40c6fe0-ec91-4856-b375-c0ffed4be83b
Route
topical
Published
Effective Date 2020-09-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
alcohol (80 mL)
Inactive Ingredients
water glycerin

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2020-08-31

Purpose

Hand Sanitizing

Description

Ethyl Alcohol (80%)


Medication Information

Warnings

Ask a doctor before use if you have

   • glaucoma

   • a breathing problem such as emphysema or chronic bronchitis

Do NOT dispose in toilet to avoid clogging. Keep in cool place indoors avoid high temperature and direct sunlight. Do NOT throw on fire.

If pregnant or breast-feeding, ask a health professional before use.

Indications and Usage

Uses Do not use on eyes and mouth area, temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

Purpose

Hand Sanitizing

Directions

Open the cover of the wet wipes or seal the sticker. After use please close the wet wipes cover or seal the sticker to keep the wet wipes moist.

       adults and children 12 years and over    Use as directed
      children 6 years to under 12 years    Use as directed
      children under 6 years    ask a doctor

Other Information

• store at 20-25° C (68-77° F)

• protect from excessive moisture

Inactive Ingredients

Aqua, Glycerine

Description

Ethyl Alcohol (80%)

Section 42229-5

%80 ALCOHOL

FORMULATION SAFE FOR HANDS

ALCOHOL CONTENT %80

WARNING

After use please close the seal to prevent water evaporation. Discontinue use if there is any wound, redness, swelling or other discomfort. Wet wipes do not dissolve in water.

PRODUCT FEATURES

Super thick soft cotton touch for increased comfort. Reverse osmosis purified water removes impurities.

Consignor:

A-K Health LLC

520 Robinson LN Unit 4, Wilmington

19805 DE (Delaware)

+1 857 272 4139

EIN: 35-2643785

ISO

GMP

PRODUCT INFORMATION

Name of Commodity:
Hand wipes

Product Specification:
140mm x 200mm / 80 Pcs. / Net Weight: 425g / Gross Weight: 450g.

Name of Commodity:
Hand wipes

Manufacturer:
AGRO GRUP TEKNOLOJI LTD. STI.

Selimpasa Mah. 6093. sk. No: 86/1

Silivri / Istanbul - Türkiye

UBB Record Number:
0080856431

Man. Licence No:
27527096

Section 50565-1

Keep out of reach of children. In case of unexpected symptoms, get medical help or contact a poison Control Center right away.

Packaging

Drug Facts

Active Ingredient

Ethyl Alcohol (80%)


Structured Label Content

Warnings

Ask a doctor before use if you have

   • glaucoma

   • a breathing problem such as emphysema or chronic bronchitis

Do NOT dispose in toilet to avoid clogging. Keep in cool place indoors avoid high temperature and direct sunlight. Do NOT throw on fire.

If pregnant or breast-feeding, ask a health professional before use.

Indications and Usage (34067-9)

Uses Do not use on eyes and mouth area, temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

Purpose

Hand Sanitizing

Directions

Open the cover of the wet wipes or seal the sticker. After use please close the wet wipes cover or seal the sticker to keep the wet wipes moist.

       adults and children 12 years and over    Use as directed
      children 6 years to under 12 years    Use as directed
      children under 6 years    ask a doctor

Other Information (Other information)

• store at 20-25° C (68-77° F)

• protect from excessive moisture

Inactive Ingredients (Inactive ingredients)

Aqua, Glycerine

Section 42229-5 (42229-5)

%80 ALCOHOL

FORMULATION SAFE FOR HANDS

ALCOHOL CONTENT %80

WARNING

After use please close the seal to prevent water evaporation. Discontinue use if there is any wound, redness, swelling or other discomfort. Wet wipes do not dissolve in water.

PRODUCT FEATURES

Super thick soft cotton touch for increased comfort. Reverse osmosis purified water removes impurities.

Consignor:

A-K Health LLC

520 Robinson LN Unit 4, Wilmington

19805 DE (Delaware)

+1 857 272 4139

EIN: 35-2643785

ISO

GMP

PRODUCT INFORMATION

Name of Commodity:
Hand wipes

Product Specification:
140mm x 200mm / 80 Pcs. / Net Weight: 425g / Gross Weight: 450g.

Name of Commodity:
Hand wipes

Manufacturer:
AGRO GRUP TEKNOLOJI LTD. STI.

Selimpasa Mah. 6093. sk. No: 86/1

Silivri / Istanbul - Türkiye

UBB Record Number:
0080856431

Man. Licence No:
27527096

Section 50565-1 (50565-1)

Keep out of reach of children. In case of unexpected symptoms, get medical help or contact a poison Control Center right away.

Packaging

Drug Facts

Active Ingredient (Active ingredient)

Ethyl Alcohol (80%)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)