49283-015-07

49283-015-07
SPL v1
SPL
SPL Set ID 452da891-98c2-0ab0-e063-6394a90a15e4
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 Coconut Oil Argan Oil Dmdm Hydantoin Trolamine Hyaluronate Sodium Cetyl Alcohol Symphytum Officinale Whole Linalool, (+/-)- Isomethyl-.alpha.-ionone Stearyl Alcohol D&c Violet No. 2 Butylphenyl Methylpropional Benzyl Salicylate .alpha.-hexylcinnamaldehyde Geraniol Methylparaben Propylparaben Lavandula Angustifolia Whole Stearic Acid Trideceth-6 Hydroxyproline Sodium Pyrrolidone Carboxylate Rosmarinus Officinalis Whole .beta.-citronellol, (r)- Water Mineral Oil Amino Acids, Wheat Panthenol

Identifiers & Packaging

Pill Appearance
Color: purple
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, 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 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.

Gelle N Detox Lavender & Rosemary Massage Lotion 0.7 Oz

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, 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 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.

Gelle N Detox Lavender & Rosemary Massage Lotion 0.7 Oz (GELLE-N-DETOX LAVENDER & ROSEMARY MASSAGE LOTION 0.7 oz)

Advanced Ingredient Data

Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:29.936673 · Updated: 2026-03-14T23:11:02.639613