CALAMINE PLUS PRAMOXINE HCL- calamine plus no touch 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. ​ Use only as directed. Intentional misuse by deliberately concentrating and inhailing contents can be harmful or fatal.

​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.

​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
• cleanse the skin with soap and water
• let dry before use
• apply as needed to the affected area, not more than 3 or 4 times daily

​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?

Call 1-866-964-0939

Principal Display Panel

Premier
Calamine Plus
No-Touch Spray

• External analgesic & skin protectant
• Drying action plus itch relief
• Ideal for poison ivy/oak/sumac, insect bites, minor skin irritations & cuts

Shake well before using

6.0 FL OZ (177mL)
Net Wt 4.1 OZ (116g)

INGREDIENTS AND APPEARANCE

CALAMINE PLUS PRAMOXINE HCL 
calamine plus no touch spray aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 56104-031
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 177 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	24.16 mg  in 177 mL
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)	PRAMOXINE HYDROCHLORIDE	2.72 mg  in 177 mL

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: 56104-031-41	177 mL in 1 CANISTER; Type 0: Not a Combination Product	01/01/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	01/01/2013

Labeler - Premier Brands of America Inc. (080051232)