Bite And Itch Lotion

Bite And Itch Lotion
SPL v3
SPL
SPL Set ID 0a4d471b-c3f3-0a6a-e063-6394a90ad57b
Route
CUTANEOUS
Published
Effective Date 2015-06-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Pramoxine (1 g) Diphenhydramine (2 g)
Inactive Ingredients
Stearyl Alcohol Menthol Methylparaben Water Isopropyl Myristate Glyceryl Stearate/peg-100 Stearate Peg-40 Glyceryl Stearate Cetyl Alcohol Propylene Glycol Diazolidinyl Urea Propylparaben

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2015-06-15

Description

Active ingredients Diphenhydramine HCl 2% Pramoxine HCl 1%


Medication Information

Warnings and Precautions

Warnings

For external use only

Do not use

  • on large areas of the body
  • with any other product containing diphenhydramine, even one taken by mouth

Ask a doctor before use if you have

  • chicken pox
  • measles

When using this product do not get into eyes

Stop use and ask a doctor if

  • condition gets worse
  • symptoms last for more than 7 days or clear up and occur again within a few days

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Indications and Usage

Uses

Temporarily relieves pain and itching due to:

  • scrapes
  • sunburn
  • minor cuts
  • minor burns
  • insect bites
  • minor skin irritations
  • poison ivy, poison oak, or poison sumac
Dosage and Administration

Directions

  • do not use more often than directed
  • adults and children 12 years and over: apply to affected area not more than 3 to 4 times daily
  • children under 12 years: ask a doctor
Description

Active ingredients Diphenhydramine HCl 2% Pramoxine HCl 1%

Section 43683-2

Added Dosage and Administration section

Updated Warnings section

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

  • conditions get worse
  • symptoms last for more than 7 days or clear up and occur again within a few days
Section 50567-7

When using this product do not get into eyes

Section 50569-3

Ask a doctor before use if you have

  • chicken pox
  • measles
Section 50570-1

Do not use

  • on large areas of the body
  • with any other product containing diphynhydramine, even one taken by mouth
Section 51727-6

Inactive ingredients

cetyl alcohol, diazolidinyl urea, glyceryl stearate, isopropyl myristate, menthol, methylparaben, PEG-100 stearate, polyoxyl 40 stearate, propylene glycol, propylparaben, purified water, stearyl alcohol

Section 51945-4

Bite and Itch

Lotion

Pramoxine HCl 1%

Topical Anesthetic

Diphenhydramine HCl 2%

Antihistamine

Pain Relieving Lotion

4 Fl Oz (118 mL)

Section 55105-1

Purposes

Topical analgesic

Topical analgesic

Section 55106-9

Active ingredients

Diphenhydramine HCl 2%

Pramoxine HCl 1%

Section 59845-8

Directions

  • do not use more often than directed
  • adults and children 12 years and over: apply to affected area not more than 3 to 4 times daily
  • children under 12 years: ask a doctor
Section 60561-8

Other information

  • store at controlled room temperature
  • call (515) 276-1586 to report any side effects that may occur

Structured Label Content

Indications and Usage (34067-9)

Uses

Temporarily relieves pain and itching due to:

  • scrapes
  • sunburn
  • minor cuts
  • minor burns
  • insect bites
  • minor skin irritations
  • poison ivy, poison oak, or poison sumac
Dosage and Administration (34068-7)

Directions

  • do not use more often than directed
  • adults and children 12 years and over: apply to affected area not more than 3 to 4 times daily
  • children under 12 years: ask a doctor
Warnings and Precautions (34071-1)

Warnings

For external use only

Do not use

  • on large areas of the body
  • with any other product containing diphenhydramine, even one taken by mouth

Ask a doctor before use if you have

  • chicken pox
  • measles

When using this product do not get into eyes

Stop use and ask a doctor if

  • condition gets worse
  • symptoms last for more than 7 days or clear up and occur again within a few days

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 43683-2 (43683-2)

Added Dosage and Administration section

Updated Warnings section

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

  • conditions get worse
  • symptoms last for more than 7 days or clear up and occur again within a few days
Section 50567-7 (50567-7)

When using this product do not get into eyes

Section 50569-3 (50569-3)

Ask a doctor before use if you have

  • chicken pox
  • measles
Section 50570-1 (50570-1)

Do not use

  • on large areas of the body
  • with any other product containing diphynhydramine, even one taken by mouth
Section 51727-6 (51727-6)

Inactive ingredients

cetyl alcohol, diazolidinyl urea, glyceryl stearate, isopropyl myristate, menthol, methylparaben, PEG-100 stearate, polyoxyl 40 stearate, propylene glycol, propylparaben, purified water, stearyl alcohol

Section 51945-4 (51945-4)

Bite and Itch

Lotion

Pramoxine HCl 1%

Topical Anesthetic

Diphenhydramine HCl 2%

Antihistamine

Pain Relieving Lotion

4 Fl Oz (118 mL)

Section 55105-1 (55105-1)

Purposes

Topical analgesic

Topical analgesic

Section 55106-9 (55106-9)

Active ingredients

Diphenhydramine HCl 2%

Pramoxine HCl 1%

Section 59845-8 (59845-8)

Directions

  • do not use more often than directed
  • adults and children 12 years and over: apply to affected area not more than 3 to 4 times daily
  • children under 12 years: ask a doctor
Section 60561-8 (60561-8)

Other information

  • store at controlled room temperature
  • call (515) 276-1586 to report any side effects that may occur

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)