zhejiang icolor biotech co., ltd

zhejiang icolor biotech co., ltd
SPL v1
SPL
SPL Set ID ab6c6629-ed2d-b483-e053-2995a90a2a53
Route
topical
Published
Effective Date 2020-07-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
benzalkonium (0.13 mg)
Inactive Ingredients
glycerin lanolin fragrance lemon orc2001060 water methylisothiazolinone iodopropynyl butylcarbamate edetate disodium polysorbate 20 vitamin a palmitate isopropyl myristate aloe vera leaf allantoin

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2020-07-27

Purpose

Antimicrobial

Description

Benzalkonium chloride 0.13%


Medication Information

Warnings
  • For external use only.
  • Do not dispose of wipes in flush toilets.
  • Flammable: Keep away from fire or flame.
Purpose

Antimicrobial

Directions
  • No rinsing required, Discard after use.
  • Apply to hands or skin.

Other Information
  • For external use only.
  • Do not dispose of wipes in flush toilets.
  • Store below 110° F (43°C)
  • May discolor certain fabrics or surfaces.
Inactive Ingredients

Water(Aqua), Methylisothiazolinone, lodopropynyl Butylcarbamate, Glycerol, disodium EDTA, AloeBarbadensisLeafJuice, Tweau, Allantion, RetinylPalmitate, Lanoliue, LsopropylMYRISTATE, Fragrance.

Description

Benzalkonium chloride 0.13%

Use

To help reduce microbes on the skin.

Section 50565-1

Keep out of reach of children: in case of accidental ingestion, get medical help or contact a poison control center immediately.

Section 50566-9

Stop using and ask a doctor if: irritation or redness develops and lasts.

Section 50567-7

When using this product: avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Active Ingredient(s)

Benzalkonium chloride 0.13%

Package Label Principal Display Panel

1pcs NDC: 74934-032-01

1pcs NDC: 74934-032-02


Structured Label Content

Warnings
  • For external use only.
  • Do not dispose of wipes in flush toilets.
  • Flammable: Keep away from fire or flame.
Purpose

Antimicrobial

Directions
  • No rinsing required, Discard after use.
  • Apply to hands or skin.

Other Information (Other information)
  • For external use only.
  • Do not dispose of wipes in flush toilets.
  • Store below 110° F (43°C)
  • May discolor certain fabrics or surfaces.
Inactive Ingredients (Inactive ingredients)

Water(Aqua), Methylisothiazolinone, lodopropynyl Butylcarbamate, Glycerol, disodium EDTA, AloeBarbadensisLeafJuice, Tweau, Allantion, RetinylPalmitate, Lanoliue, LsopropylMYRISTATE, Fragrance.

Use

To help reduce microbes on the skin.

Section 50565-1 (50565-1)

Keep out of reach of children: in case of accidental ingestion, get medical help or contact a poison control center immediately.

Section 50566-9 (50566-9)

Stop using and ask a doctor if: irritation or redness develops and lasts.

Section 50567-7 (50567-7)

When using this product: avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Active Ingredient(s)

Benzalkonium chloride 0.13%

Package Label Principal Display Panel (Package Label - Principal Display Panel)

1pcs NDC: 74934-032-01

1pcs NDC: 74934-032-02


Advanced Ingredient Data


Raw Label Data

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