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
Description

Benzalkonium chloride 0.13%

Purpose

Antimicrobial

Medication Information

Purpose

Antimicrobial

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.

Warnings
  • For external use only.
  • Do not dispose of wipes in flush toilets.
  • Flammable: Keep away from fire or flame.
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.
Active Ingredient(s)

Benzalkonium chloride 0.13%

Inactive Ingredients

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

Package Label Principal Display Panel

1pcs NDC: 74934-032-01

1pcs NDC: 74934-032-02

Structured Label Content

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.

Purpose

Antimicrobial

Warnings
  • For external use only.
  • Do not dispose of wipes in flush toilets.
  • Flammable: Keep away from fire or flame.
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.
Active Ingredient(s)

Benzalkonium chloride 0.13%

Inactive Ingredients (Inactive ingredients)

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

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

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:58:18.909243 · Updated: 2026-03-14T22:57:49.309992