Leader Original Anti Itch Lotion

Leader Original Anti Itch Lotion
SPL v7
SPL
SPL Set ID 9ca985c6-5017-0558-e053-2995a90a8202
Route
TOPICAL
Published
Effective Date 2020-01-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Camphor (synthetic) (0.5 g) Menthol, Unspecified Form
Inactive Ingredients
Carbomer Interpolymer Type A (55000 Cps) Isopropyl Myristate Water Peg-40 Stearate Cetyl Alcohol Peg-100 Stearate Stearic Acid Dmdm Hydantoin Sodium Hydroxide Petrolatum Glyceryl Stearate Se

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-01-21

Description

Camphor 0.5% Menthol 0.5%


Medication Information

Warnings and Precautions

For external use only

Indications and Usage

temporary relieves pain and itching due to:

insect bites

minor burns

sunburn

minor skin irritations

minor cuts

scrapes

rashes due to poison ivy, poison oak, and poison sumac

Description

Camphor 0.5% Menthol 0.5%

Section 43683-2

Update to version number to the most recent label with updated inactive ingredient list

Updated Titles to remove repeats of Section Type

Section 50565-1

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

Section 50566-9

condition worsens

symptoms last more than 7 days or clear up and occur again within a few days

Section 50567-7

do not get into eyes

Section 50569-3

on chicken pox

on measles

Section 51727-6

carbomer interpolymer type A, cetyl alcohol, DMDM hydantoin, fragrance, glyceryl

stearate, isopropyl myristate, PEG-40 stearate, PEG-100 stearate,

purified water, sodium hydroxide, stearic acid, white petrolatum

Section 51945-4

Compare to Sarna Original Anti-Itch lotion

Original Formula Anti-Itch Lotion

Camphor 0.5%

Menthol 0.5%

Steroid Free

Relief from itching associated with dry skin, insectr bites, poison ivy and Sunburn

Cools and Soothes

Section 55105-1

Anti-itch

External Analgesic

Section 55106-9

Camphor 0.5%

Menthol 0.5%

Directions

to open, squeeze cap tightly and turn pump counter-clockwise

adults and children 2 years and older: apply to affected area not more than 3 to 4 times daily

children under 2 years: ask a doctor

Other Information

store at 20 °C to 25 °C (68 °F to 77 °F)


Structured Label Content

Indications and Usage (34067-9)

temporary relieves pain and itching due to:

insect bites

minor burns

sunburn

minor skin irritations

minor cuts

scrapes

rashes due to poison ivy, poison oak, and poison sumac

Warnings and Precautions (34071-1)

For external use only

Section 43683-2 (43683-2)

Update to version number to the most recent label with updated inactive ingredient list

Updated Titles to remove repeats of Section Type

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

condition worsens

symptoms last more than 7 days or clear up and occur again within a few days

Section 50567-7 (50567-7)

do not get into eyes

Section 50569-3 (50569-3)

on chicken pox

on measles

Section 51727-6 (51727-6)

carbomer interpolymer type A, cetyl alcohol, DMDM hydantoin, fragrance, glyceryl

stearate, isopropyl myristate, PEG-40 stearate, PEG-100 stearate,

purified water, sodium hydroxide, stearic acid, white petrolatum

Section 51945-4 (51945-4)

Compare to Sarna Original Anti-Itch lotion

Original Formula Anti-Itch Lotion

Camphor 0.5%

Menthol 0.5%

Steroid Free

Relief from itching associated with dry skin, insectr bites, poison ivy and Sunburn

Cools and Soothes

Section 55105-1 (55105-1)

Anti-itch

External Analgesic

Section 55106-9 (55106-9)

Camphor 0.5%

Menthol 0.5%

Directions

to open, squeeze cap tightly and turn pump counter-clockwise

adults and children 2 years and older: apply to affected area not more than 3 to 4 times daily

children under 2 years: ask a doctor

Other Information (Other information)

store at 20 °C to 25 °C (68 °F to 77 °F)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)