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 Topco Associates LLC. 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.

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?

Call 1-866-964-0939

Principal Display Panel

TopCare

NO TOUCH

Calamine Plus Spray

Calamine 8% - Skin Protectant

Promoxine HCL 1% - External Analgesic

Drying action plus itch relief

Ideal for: poison ivy/oak/sumac

insect bites, minor skin irritations & cuts

SHAKE WELL BEFORE USE

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: 36800-398
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 CATION - UNII:13S1S8SF37)	ZINC CATION	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)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
ISOBUTANE (UNII: BXR49TP611)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
ALCOHOL (UNII: 3K9958V90M)
SORBITAN TRIOLEATE (UNII: QE6F49RPJ1)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-398-41	116 g in 1 CANISTER; Type 0: Not a Combination Product	01/01/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	01/01/2017

Labeler - Topco Associates LLC (006935977)