careone calamine plus spray

careone calamine plus spray
SPL v5
SPL
SPL Set ID 7cad7ad7-347a-6992-e053-2a91aa0a9ad6
Route
topical
Published
Effective Date 2018-12-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
zinc oxide (24.16 mg) pramoxine (2.72 mg) ferric oxide red (0.345 mg)
Inactive Ingredients
hydrated silica oleyl alcohol alcohol sorbitan trioleate disteardimonium hectorite isobutane benzyl alcohol camphor (synthetic)

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2019-02-01

Purpose

Skin protectant External analgesic

Description

Calamine 8% Pramoxine HCl 1%


Medication Information

Warnings

For external use only.

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
Purpose

Skin protectant

External analgesic

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

Description

Calamine 8% Pramoxine HCl 1%

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 IRRITATIONS AND CUTS

Shake well before use

NET WT 4.1 OZ (116g)

Questions?

Call 1-866-964-0939

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.

Active Ingredient

Calamine 8%

Pramoxine HCl 1%

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.


Structured Label Content

Warnings

For external use only.

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
Purpose

Skin protectant

External analgesic

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 (Other information)

store between 20° to 25°C (68° to 77°F)

Inactive Ingredients (Inactive ingredients)

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

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 IRRITATIONS AND CUTS

Shake well before use

NET WT 4.1 OZ (116g)

Questions?

Call 1-866-964-0939

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.

Active Ingredient

Calamine 8%

Pramoxine HCl 1%

When Using This Product (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 (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. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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