49283-110-07

49283-110-07
SPL v3
SPL
SPL Set ID f2a107aa-5ad3-7bad-e053-2a95a90a1d97
Route
TOPICAL
Published
Effective Date 2023-09-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.1 g)
Inactive Ingredients
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 Completed Since 2023-01-19 Until 2027-12-31

Description

Benzalkonium Chloride 0.1%


Medication Information

Warnings and Precautions

For external use only.

Do not use on wounds or damaged skin, with a heating pad or on a child under 12 years of age.

Description

Benzalkonium Chloride 0.1%

Uses:

To decrease bacteria on the skin.

Section 50565-1

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

right away

Section 50567-7

•Avoid contact with the eyes.

• Do not apply to the irritated skin or if excessive irritation develops.

Section 50569-3

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

Section 51727-6

Water (Aqua), Paraffinum Liquidum, Stearic Acid, Cetyl Alcohol, Fragrance (Parfum), Stearyl Alcohol, DMDM Hydantoin, Triethanolamine, Acrylamide/Sodium Acrylate Copolymer, Trideceth-6, Methylparaben, Propylparaben, Cocos Nucifera Oil (Organic), Argania Spinosa Kernel Oil (Organic), Lavandula Angustifolia (Lavender) Extract, Rosmarinus Officinalis (Rosemary) Extract, Sodium Hyaluronate, Sodium PCA, Wheat Amino Acids, Panthenol, Symphytum Officinale (Comfrey) Extract, Hydroxyproline, D&C Violet No.2 (CI 60730), Benzyl Salicylate, Linalool, Hexyl Cinnamal, Alpha Isomethyl Ionone, Citronellol, Geraniol.

Section 51945-4

Section 53413-1

Call (305) 623-4445

Section 53414-9

Ask a health professional before use.

Section 55105-1

Antimicrobial

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:

Apply a full-palm amount or as needed to cover the affected area (hands, feet, body). Rub until absorbed.


Structured Label Content

Uses: (USES:)

To decrease bacteria on the skin.

Warnings and Precautions (34071-1)

For external use only.

Do not use on wounds or damaged skin, with a heating pad or on a child under 12 years of age.

Section 50565-1 (50565-1)

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

right away

Section 50567-7 (50567-7)

•Avoid contact with the eyes.

• Do not apply to the irritated skin or if excessive irritation develops.

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, Stearic Acid, Cetyl Alcohol, Fragrance (Parfum), Stearyl Alcohol, DMDM Hydantoin, Triethanolamine, Acrylamide/Sodium Acrylate Copolymer, Trideceth-6, Methylparaben, Propylparaben, Cocos Nucifera Oil (Organic), Argania Spinosa Kernel Oil (Organic), Lavandula Angustifolia (Lavender) Extract, Rosmarinus Officinalis (Rosemary) Extract, Sodium Hyaluronate, Sodium PCA, Wheat Amino Acids, Panthenol, Symphytum Officinale (Comfrey) Extract, Hydroxyproline, D&C Violet No.2 (CI 60730), Benzyl Salicylate, Linalool, Hexyl Cinnamal, Alpha Isomethyl Ionone, Citronellol, Geraniol.

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)

Antimicrobial

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: (DIRECTIONS:)

Apply a full-palm amount or as needed to cover the affected area (hands, feet, body). Rub until absorbed.


Advanced Ingredient Data


Raw Label Data

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