b210bd9a-126f-57e4-e053-2995a90a90c6

SPL v1
SPL
SPL Set ID b210bd9a-126f-57e4-e053-2995a90a90c6
Route
topical
Published
Effective Date 2020-10-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
alcohol (75 mL)
Inactive Ingredients
water carbomer homopolymer, unspecified type benzalkonium chloride

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2020-10-12

Description

Alcohol 75%


Medication Information

Warnings and Precautions

WARNINGS: For external use only

Flammable: Keep away form heat and flame

Active Ingredient

Alcohol 75%

Indications and Usage

Uses

To decrease bacteria on the skin that could cause disease

Recommended for repeated use

Dosage and Administration

Directions

Wet hands thoroughly with product and allow to dry without wiping

Not recommended for infants

Description

Alcohol 75%

Section 42229-5

Alcohol antiseptic 75% topical solution

NON-STERILE SOLUTION

KILL 99.9% OF GERMS

500ml/16.9 fl oz

FEATURES & DETAILS:

  • Helps reduce the risk of infections
  • Leaves no sitckiness or residue on hands
  • Removes light soils and dirt form hands
  • Paraben Free

Manufactured by Shandong Fengrui Biotechnology Co., Ltd.

Manufactured in No.168, Qingwei Road, Dongliuting Community, Liuting Sub-District, Qingdao,CHN

NDC 80832-003-01

Section 44425-7

Other information:

  • Do not store above 105 ℉
  • May discolor some fabrics harmful to wood finishes and plastics
Section 50565-1

If swallowed, get medical help or contact a poison control center right away

Section 50566-9

Stop use and ask a doctor

  • if irritation or redness develops
  • condition persists for more than 72 hours
Section 50567-7

Keep out of eyes

In case fo contact with thoroughly with water

Avoid contact with broken skin

Do not inhale or ingest

Section 51727-6

Benzalkonium Chloride 0.03%, water(aqua)

Section 51945-4

500ML NDC 80832-003-01

Section 55105-1

Antiseptic


Structured Label Content

Warnings and Precautions (34071-1)

WARNINGS: For external use only

Flammable: Keep away form heat and flame

Active Ingredient (55106-9)

Alcohol 75%

Indications and Usage (34067-9)

Uses

To decrease bacteria on the skin that could cause disease

Recommended for repeated use

Dosage and Administration (34068-7)

Directions

Wet hands thoroughly with product and allow to dry without wiping

Not recommended for infants

Section 42229-5 (42229-5)

Alcohol antiseptic 75% topical solution

NON-STERILE SOLUTION

KILL 99.9% OF GERMS

500ml/16.9 fl oz

FEATURES & DETAILS:

  • Helps reduce the risk of infections
  • Leaves no sitckiness or residue on hands
  • Removes light soils and dirt form hands
  • Paraben Free

Manufactured by Shandong Fengrui Biotechnology Co., Ltd.

Manufactured in No.168, Qingwei Road, Dongliuting Community, Liuting Sub-District, Qingdao,CHN

NDC 80832-003-01

Section 44425-7 (44425-7)

Other information:

  • Do not store above 105 ℉
  • May discolor some fabrics harmful to wood finishes and plastics
Section 50565-1 (50565-1)

If swallowed, get medical help or contact a poison control center right away

Section 50566-9 (50566-9)

Stop use and ask a doctor

  • if irritation or redness develops
  • condition persists for more than 72 hours
Section 50567-7 (50567-7)

Keep out of eyes

In case fo contact with thoroughly with water

Avoid contact with broken skin

Do not inhale or ingest

Section 51727-6 (51727-6)

Benzalkonium Chloride 0.03%, water(aqua)

Section 51945-4 (51945-4)

500ML NDC 80832-003-01

Section 55105-1 (55105-1)

Antiseptic


Advanced Ingredient Data


Raw Label Data

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