CALAMINE PLUS PRAMOXINE HCL- calamine plus spray aerosol, spray

Calamine Plus Pramoxine HCl by

Drug Labeling and Warnings

Calamine Plus Pramoxine HCl by is a Otc medication manufactured, distributed, or labeled by Premier Brands of America, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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)

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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)

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

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

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