Licefreee Afterlice Spray

Licefreee Afterlice Spray
SPL v2
SPL
SPL Set ID 06c4cc42-a215-3949-e063-6394a90a665e
Route
TOPICAL
Published
Effective Date 2023-10-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Pramoxine (10 mg)
Inactive Ingredients
Tea Tree Oil Benzethonium Chloride Menthol Polyoxyl 35 Castor Oil Alcohol Water Panthenol Polyquaternium-10 (400 Cps At 2%)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-10-16

Description

Active ingredient Pramoxine HCI 1%


Medication Information

Warnings and Precautions

For external use only

Indications and Usage

Uses

for the temporary relief of itching associated with

  • insect bites
  • minor skin irritations
Dosage and Administration

Directions

  • Adults and children 2 years of age and older: spray on affected area not more than 3-4 times daily
  • Children under 2 years; do not use; consult a doctor

Description

Active ingredient Pramoxine HCI 1%

Section 44425-7

Other Information

Store at 59-86ºF (15-30ºC)

Section 50565-1

Keep out of reach of children

  • If swallowed, get medical help or contact a Poison Control Center right away.
Section 50566-9

Stop use and ask a doctor if

  • condition worstens
  • symptoms last more than 7 days or clear up and occur again within a few days
Section 50567-7

When using this product

  • avoid contact with eyes
Section 51727-6

Inactive ingredients

alcohol, benzethonium CI, menthol, panthenol, polyoxyl 35 castor oil, polyquaternium-10, purified water, tea tree oil

Section 51945-4

Section 53413-1

Questions or comments?

Call 1-800-482-4464.

Section 55105-1

Pain and itch relief spray for scalp irritation caused by lice bites and lice treatments.

Section 55106-9

Active ingredient

Pramoxine HCI 1%


Structured Label Content

Indications and Usage (34067-9)

Uses

for the temporary relief of itching associated with

  • insect bites
  • minor skin irritations
Dosage and Administration (34068-7)

Directions

  • Adults and children 2 years of age and older: spray on affected area not more than 3-4 times daily
  • Children under 2 years; do not use; consult a doctor

Warnings and Precautions (34071-1)

For external use only

Section 44425-7 (44425-7)

Other Information

Store at 59-86ºF (15-30ºC)

Section 50565-1 (50565-1)

Keep out of reach of children

  • If swallowed, get medical help or contact a Poison Control Center right away.
Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • condition worstens
  • symptoms last more than 7 days or clear up and occur again within a few days
Section 50567-7 (50567-7)

When using this product

  • avoid contact with eyes
Section 51727-6 (51727-6)

Inactive ingredients

alcohol, benzethonium CI, menthol, panthenol, polyoxyl 35 castor oil, polyquaternium-10, purified water, tea tree oil

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments?

Call 1-800-482-4464.

Section 55105-1 (55105-1)

Pain and itch relief spray for scalp irritation caused by lice bites and lice treatments.

Section 55106-9 (55106-9)

Active ingredient

Pramoxine HCI 1%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)