Active ingredient

Calamine 8%
Pramoxine HCl 1%

Purpose

Skin protectant
External analgesic

Uses

temporarily relieves pain and itching associated with:

insect bites
rashes
minor skin irritations
minor cuts
dries the oozing and weeping of poison ivy, poison oak and poison sumac

Warnings

For external use only.

Flammable:

Do not use while smoking or near heat or flame. Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120°F. Intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal.

When using this product

do not get into eyes
ask a doctor before using on children under 2 years of age

Stop use and ask a doctor if

conditions worsens
symtomps last more than 7 days or clear up and occur again in a few days

Keep out of reach of children.

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

Directions

shake well before using
adults and children 2 years of age and older: apply as needed to the affected area, not more than 3 or 4 times daily
cleanse the skin with soap and water
let dry before use
children under 2 years of age: consult a doctor

Other information

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

Inactive ingredients

benzyl alcohol, camphor, disteardimonium hectorite, fragrance, hydrated silica, isobutane, oleyl alcohol, SD alcohol 40-B, sorbitan trioleate

Questions?

800-632-6900

Principal Display Panel

Cutter

Poison Ivy Drying & Soothing

Triple Action

Dries oozing & weeping

Soothes pain

Calms itching

Calamine 8%

Skin Protectant

Pramoxine HCl 1%

External Analgesic

NET WT 4.1 OZ (116g)

Artwork

CALAMINE PLUS PRAMOXINE HCL
calamine plus spray aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:56104-251
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
FERRIC OXIDE RED (UNII: 1K09F3G675) (FERRIC OXIDE RED - UNII:1K09F3G675)	FERRIC OXIDE RED	0.345 mg in 116 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	24.16 mg in 116 g
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)	PRAMOXINE HYDROCHLORIDE	2.72 mg in 116 g

Ingredient Name	Strength
Inactive Ingredients
BENZYL ALCOHOL (UNII: LKG8494WBH)
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
ISOBUTANE (UNII: BXR49TP611)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
SORBITAN TRIOLEATE (UNII: QE6F49RPJ1)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
ALCOHOL (UNII: 3K9958V90M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:56104-251-00	116 g in 1 CANISTER; Type 0: Not a Combination Product	12/20/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M017	12/20/2021

Labeler - Premier Brands of America, Inc. (063849780)

Cutter Poison Ivy Drying & Soothing Spray

Active ingredient

Purpose

Uses

​Warnings

​Flammable:

​When using this product