Calamine Plus Pramoxine HCl: Package Insert and Label Information

CALAMINE PLUS PRAMOXINE HCL- zinc oxide, pramoxine hydrochloride and ferric oxide red aerosol, spray
Foodhold USA

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 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 temperature above 120ºF. Intentional misuse by delibrately 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
  • symptoms 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

CAREONE

NO-RUB CALAMINE SPRAY

Calamine 8%/ Skin Protectant

Pramoxine HCl 1%/ External Analgesic

TEMPORARILY RELIEVES ITCHING FROM POISON IVY, OAK & SUMAC, AND INSECT BITES

SOOTHES MINOR SKIN IRRITATIONA AND CUTS

Shake well before use

NET WT 4.1 OZ (116g)

Calamine Plus 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:41520-184
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 24.16 mg in 116 g
PRAMOXINE HYDROCHLORIDE (PRAMOXINE) PRAMOXINE HYDROCHLORIDE 2.72 mg in 116 g
FERRIC OXIDE RED (FERRIC OXIDE RED) FERRIC OXIDE RED 0.345 mg in 116 g
Inactive Ingredients
Ingredient Name Strength
HYDRATED SILICA
OLEYL ALCOHOL
ALCOHOL
SORBITAN TRIOLEATE
DISTEARDIMONIUM HECTORITE
ISOBUTANE
BENZYL ALCOHOL
CAMPHOR (SYNTHETIC)
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:41520-184-41 116 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 02/01/2019
Labeler — Foodhold USA (809183973)

Revised: 12/2018 Foodhold USA

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