49283-014-07

49283-014-07
SPL v1
SPL
SPL Set ID 452e11db-b4f2-a95b-e063-6394a90a95cc
Route
TOPICAL
Published
Effective Date 2025-12-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.1 g)
Inactive Ingredients
Carbomer Homopolymer Type C Trideceth-6 Hyaluronate Sodium Sodium Pyrrolidone Carboxylate Amino Acids, Wheat Symphytum Officinale Whole Fd&c Blue No. 1 Citral Limonene, (+)- Water Stearyl Alcohol Methyl Salicylate Panthenol Eucalyptus Oil Mineral Oil Stearic Acid Trolamine Propylparaben Argan Oil Fd&c Yellow No. 5 Coconut Oil Methylparaben Dmdm Hydantoin Hydroxyproline Geraniol Linalool, (+)-

Identifiers & Packaging

Pill Appearance
Color: green
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-12-04
Description

Benzalkonium Chloride 0.1%

Medication Information

Warnings and Precautions
  • For external use only.
  • Do not use in the eyes or apply over large areas of the body.
  • In case of deep or puncture wounds, animal bites, or serious burns, consult a doctor.
  • Stop use and ask a doctor if the condition persists or gets worse.
  • Do not use longer than 1 week unless directed by a doctor
Description

Benzalkonium Chloride 0.1%

Uses

First aid to help protect against bacterial contamination.

Section 50565-1

If swallowed, get medical help or contact a Poison Control Center

right away

Section 50569-3

Ask a doctor before use if you have redness over affected area.

Section 51727-6

Water (Aqua), Paraffinum Liquidum, Cetyl Alcohol, Stearic Acid, Stearyl Alcohol, Fragrance (Parfum), DMDM Hydantoin, Triethanolamine, Acrylamide/Sodium Acrylate Copolymer, Trideceth-6, Methylparaben, Propylparaben, Cocos Nucifera Oil (Organic), Argania Spinosa Kernel Oil (Organic), Methyl Salicylate, Eucalyptus Globulus Leaf Oil, Sodium Hyaluronate, Sodium PCA, Wheat Amino Acids, Panthenol, Symphytum Officinale (Comfrey) Extract, Hydroxyproline, FD&C Yellow No.5 (CI 19140), FD&C Blue No.1 (CI 42090), Citral, D-Limonene, Geraniol, Linalool.

Section 51945-4

Section 53413-1

Call (305) 623-4445

Section 53414-9

Ask a health professional before use.

Section 55105-1

Antiseptic

Section 55106-9

Benzalkonium Chloride 0.1%

Section 60561-8

Store tightly closed in a dry place at controlled room temperature between 59°-86° F (15°-30° C).

Directions

Adults and children 12 years of age or older: • Clean the affected area. • Apply a small amount of this product on the area 1 to 3 times daily. • May be covered with a sterile bandage. Children under 12 years of age: do not use, consult a doctor.

Structured Label Content

Uses

First aid to help protect against bacterial contamination.

Warnings and Precautions (34071-1)
  • For external use only.
  • Do not use in the eyes or apply over large areas of the body.
  • In case of deep or puncture wounds, animal bites, or serious burns, consult a doctor.
  • Stop use and ask a doctor if the condition persists or gets worse.
  • Do not use longer than 1 week unless directed by a doctor
Section 50565-1 (50565-1)

If swallowed, get medical help or contact a Poison Control Center

right away

Section 50569-3 (50569-3)

Ask a doctor before use if you have redness over affected area.

Section 51727-6 (51727-6)

Water (Aqua), Paraffinum Liquidum, Cetyl Alcohol, Stearic Acid, Stearyl Alcohol, Fragrance (Parfum), DMDM Hydantoin, Triethanolamine, Acrylamide/Sodium Acrylate Copolymer, Trideceth-6, Methylparaben, Propylparaben, Cocos Nucifera Oil (Organic), Argania Spinosa Kernel Oil (Organic), Methyl Salicylate, Eucalyptus Globulus Leaf Oil, Sodium Hyaluronate, Sodium PCA, Wheat Amino Acids, Panthenol, Symphytum Officinale (Comfrey) Extract, Hydroxyproline, FD&C Yellow No.5 (CI 19140), FD&C Blue No.1 (CI 42090), Citral, D-Limonene, Geraniol, Linalool.

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Call (305) 623-4445

Section 53414-9 (53414-9)

Ask a health professional before use.

Section 55105-1 (55105-1)

Antiseptic

Section 55106-9 (55106-9)

Benzalkonium Chloride 0.1%

Section 60561-8 (60561-8)

Store tightly closed in a dry place at controlled room temperature between 59°-86° F (15°-30° C).

Directions

Adults and children 12 years of age or older: • Clean the affected area. • Apply a small amount of this product on the area 1 to 3 times daily. • May be covered with a sterile bandage. Children under 12 years of age: do not use, consult a doctor.

Advanced Ingredient Data

Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:29.938549 · Updated: 2026-03-14T23:11:02.639613