Calamine Plus Pramoxine HCL: Package Insert and Label Information

CALAMINE PLUS PRAMOXINE HCL- ferric oxide red, pramoxine hydrochloride and zinc oxide aerosol, spray
Meijer Distribution Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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)

calamine spray
(click image for full-size original)
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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FERRIC OXIDE RED (FERRIC OXIDE RED) FERRIC OXIDE RED 0.345 mg in 116 g
PRAMOXINE HYDROCHLORIDE (PRAMOXINE) PRAMOXINE HYDROCHLORIDE 2.72 mg in 116 g
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 24.16 mg in 116 g
Inactive Ingredients
Ingredient Name Strength
ISOBUTANE
BENZYL ALCOHOL
OLEYL ALCOHOL
SORBITAN TRIOLEATE
ALCOHOL
HYDRATED SILICA
DISTEARDIMONIUM HECTORITE
CAMPHOR (SYNTHETIC)
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:41250-235-41 116 g in 1 CANISTER None
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)

Revised: 08/2019 Meijer Distribution Inc.

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