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 Meijer Distribution Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Calamine 8%

Pramoxine HCI 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

• condition worsens
• symptoms last more than 7 days or clear up and occur again in a few days

Keep out of the 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 to affected area not more than 3 to 4 times daily
• cleanse the skin with soap and water
• let dry before use
• children under 2 years of age: consult a doctor

Inactive ingredients

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

Questions?

Call 1-866-964-0939

Principal Display Panel

meijer

NO-RUB

calamine plus spray

Calamine Pramoxine HCI

Skin Protectant

External Analgesic

SHAKE WELL BEFORE USE

Relieves itching from poison ivy, oak & sumac, & insect bites

Soothes minor skin irritations & cuts

NET WT 4.1 OZ (116 g)

INGREDIENTS AND APPEARANCE

CALAMINE PLUS PRAMOXINE HCL 
calamine plus spray aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41250-235
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
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)	PRAMOXINE HYDROCHLORIDE	2.72 mg  in 116 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	24.16 mg  in 116 g

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41250-235-41	116 g in 1 CANISTER; Type 0: Not a Combination Product	03/14/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	03/14/2020

Labeler - Meijer Distribution Inc. (006959555)