insect bites relief spray

insect bites relief spray
SPL v2
SPL
SPL Set ID 006e457d-bfcd-791a-e063-6294a90a8d66
Route
topical
Published
Effective Date 2022-10-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
menthol (1 g)
Inactive Ingredients
alcohol water menthyl lactate, (-)- borneol butylene glycol glycerin

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2022-09-30

Purpose

Anti-itch Insect bite relief spray

Description

Menthol 1%


Medication Information

Warnings

For external use only.

Uses

Temporarily relieves itching associated with minor skin irritations, inflammation and rashes due to: eczema, psoriasis, insect bites, detergents, jewelry, cosmetics, soaps, seborrheic dermatitis and more.

Indications and Usage

Do not begin use of any hydrocortisone product unless you've asked a doctor. Do not use in the genital area if you have a vaginal discharge. Consult a doctor. Do not use more than directed unless told to do so by a doctor.

Purpose

Anti-itch

Insect bite relief spray

Directions
  • Apply to affected area not more than 3 to 4 times daily.
  • Children under 2 years, do not use; ask a doctor.
Other Information

Protect from excessive heat (40 oC/ 104 oF)

Inactive Ingredients

Alcohol, Aqua, Menthyl Lactate, Borneol, Butylene Glycol, Glycerin

Description

Menthol 1%

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 worsens or if symptoms persist for more than 7 days
  • symptoms last more than 7 days or clear up and occur again within a few days
Section 50567-7

Ask a doctor before use if you are using any other hydrocortisone product.

Section 51945-4

Do Not Use
  • in or near the eyes
  • for disper rash; ask a doctor
Active Ingredients

Menthol 1%


Structured Label Content

Warnings

For external use only.

Uses

Temporarily relieves itching associated with minor skin irritations, inflammation and rashes due to: eczema, psoriasis, insect bites, detergents, jewelry, cosmetics, soaps, seborrheic dermatitis and more.

Indications and Usage (34067-9)

Do not begin use of any hydrocortisone product unless you've asked a doctor. Do not use in the genital area if you have a vaginal discharge. Consult a doctor. Do not use more than directed unless told to do so by a doctor.

Purpose

Anti-itch

Insect bite relief spray

Directions
  • Apply to affected area not more than 3 to 4 times daily.
  • Children under 2 years, do not use; ask a doctor.
Other Information (Other information)

Protect from excessive heat (40 oC/ 104 oF)

Inactive Ingredients (Inactive ingredients)

Alcohol, Aqua, Menthyl Lactate, Borneol, Butylene Glycol, Glycerin

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 worsens or if symptoms persist for more than 7 days
  • symptoms last more than 7 days or clear up and occur again within a few days
Section 50567-7 (50567-7)

Ask a doctor before use if you are using any other hydrocortisone product.

Section 51945-4 (51945-4)

Do Not Use (Do not use)
  • in or near the eyes
  • for disper rash; ask a doctor
Active Ingredients

Menthol 1%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)