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SPL v18
SPL
SPL Set ID b01fe801-7316-11df-93f2-0800200c9a66
Route
topical
Published
Effective Date 2025-11-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
echinacea angustifolia (1 [hp_X]) ledum palustre twig (2 [hp_X]) urtica dioica
Inactive Ingredients
citronella oil alcohol eucalyptus oil jojoba oil carbomer homopolymer type c water sodium hydroxide witch hazel

Identifiers & Packaging

Marketing Status
unapproved homeopathic completed Since 2004-07-01 Until 2026-04-30

Purpose

Temporarily relieves the pain, itch, redness, and swelling of minor insect bites and stings (ants, bees, mosquitos, wasps, etc). Soothes fever blisters and cold sores.

Description

Echinacia angustifoloia 1X Ledum palustre 2X Urtica dioica 1X


Medication Information

Warnings

For external use only. Avoid contact with eyes and broken skin.

Purpose

Temporarily relieves the pain, itch, redness, and swelling of minor insect bites and stings (ants, bees, mosquitos, wasps, etc).

Soothes fever blisters and cold sores.

Description

Echinacia angustifoloia 1X Ledum palustre 2X Urtica dioica 1X

Section 51945-4

Stop Use

Stop use and ask a doctor if skin irritation, rash, or other allergic reaction develops, condition worsens or does not improve within 7 days.

These could be signs of a serious condition.

Do Not Use

Do not use if hypersensitive to plants in the Asteraceae (Compositae) family or any other ingredients in this product.

Breast-feeding women should not apply to breast area.

Overdosage

If swallowed, seek medical help or contact a Poison Control Center right away.

Active Ingredients

Echinacia angustifoloia 1X

Ledum palustre 2X

Urtica dioica 1X

Inactive Ingredient

Carbomer

Citronella Oil

Ethyl Alcohol

Eucalyptus Oil

Jojoba Oil

Purified Water

Sodium Hydroxide

Witch Hazel Distillate

Indications & Usage

Temporarily relieves the pain, itch, redness, and swelling of minor insect bites and stings (ants, bees, mosquitos, wasps, etc).

Soothes fever blisters and cold sores.

Dosage & Administration

Directions:

Adults & children 6 years of age and older: Apply to affected area; repeat as needed.

Patch test recommended on sensitive skin.

Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a healthcare professional before use.

Keep Out of Reach of Children

Keep out of reach of children.


Structured Label Content

Warnings

For external use only. Avoid contact with eyes and broken skin.

Purpose

Temporarily relieves the pain, itch, redness, and swelling of minor insect bites and stings (ants, bees, mosquitos, wasps, etc).

Soothes fever blisters and cold sores.

Section 51945-4 (51945-4)

Stop Use

Stop use and ask a doctor if skin irritation, rash, or other allergic reaction develops, condition worsens or does not improve within 7 days.

These could be signs of a serious condition.

Do Not Use (Do not use)

Do not use if hypersensitive to plants in the Asteraceae (Compositae) family or any other ingredients in this product.

Breast-feeding women should not apply to breast area.

Overdosage

If swallowed, seek medical help or contact a Poison Control Center right away.

Active Ingredients

Echinacia angustifoloia 1X

Ledum palustre 2X

Urtica dioica 1X

Inactive Ingredient

Carbomer

Citronella Oil

Ethyl Alcohol

Eucalyptus Oil

Jojoba Oil

Purified Water

Sodium Hydroxide

Witch Hazel Distillate

Indications & Usage

Temporarily relieves the pain, itch, redness, and swelling of minor insect bites and stings (ants, bees, mosquitos, wasps, etc).

Soothes fever blisters and cold sores.

Dosage & Administration

Directions:

Adults & children 6 years of age and older: Apply to affected area; repeat as needed.

Patch test recommended on sensitive skin.

Pregnancy Or Breast Feeding (Pregnancy or breast feeding)

If pregnant or breast-feeding, ask a healthcare professional before use.

Keep Out of Reach of Children (Keep out of reach of children)

Keep out of reach of children.


Advanced Ingredient Data


Raw Label Data

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