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 Kroger Co.. 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

Kroger

Calamine

Plus Spray

Calamine 8%

Skin Protectant

Pramoxine HCl 1%

External Analgesic

Relieves Itching From

Poison Ivy, Oak & Sumac,

& Insect Bites

Soothes Minor Skin

Irritations & Cuts

Shake Well Before Use

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: 30142-156
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: 30142-156-06	116 g in 1 CANISTER; Type 0: Not a Combination Product	12/06/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	12/06/2017

Labeler - Kroger Co. (006999528)