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

Active Ingredient

Camphor 0.5%

Menthol 0.5%

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

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)

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


Structured Label Content

Warnings and Precautions (34071-1)

For external use only

Active Ingredient (55106-9)

Camphor 0.5%

Menthol 0.5%

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

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)

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)