Premier Solutions Calamine Plus Spray

Premier Solutions Calamine Plus Spray
SPL v3
SPL
SPL Set ID 36481d67-2346-470b-e063-6294a90aae99
Route
TOPICAL
Published
Effective Date 2025-05-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ferric Oxide Red (5 mg) Zinc Oxide (75 mg) Pramoxine (10 mg)
Inactive Ingredients
Camphor (synthetic) Hydrated Silica Isobutane Oleyl Alcohol Benzyl Alcohol Sorbitan Trioleate Disteardimonium Hectorite Alcohol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-05-28

Description

Calamine 8% Pramoxine HCl 1%

Purpose

Skin protectant External analgesic


Medication Information

Purpose

Skin protectant

External analgesic

Description

Calamine 8% Pramoxine HCl 1%

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
Section 43683-2

.

Directions
  • shake well before using
  • adults and children 2 years of age and older: apply to 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
​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 inhailing contents can be harmful or fatal.

​questions?

Call 1-866-964-0939

Active Ingredient

Calamine 8%

Pramoxine HCl 1%

​other Information

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

Principal Display Panel

Premier

solutions



NO-RUB

CALAMINE

PLUS SPRAY

CALAMINE 8% / SKIN PROTECTANT

PRAMOXINE HCL 1% / EXTERNAL ANALGESIC

RELIEVES ITCHING FROM

POISON IVY, OAK & SUMAC,

PLUS INSECT BITES

Soothes minor skin irritations & cuts



SHAKE WELL!



NET WT. 4.1 OZ. (116g)

​inactive Ingredients

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

​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.


Structured Label Content

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
Section 43683-2 (43683-2)

.

Purpose

Skin protectant

External analgesic

Directions
  • shake well before using
  • adults and children 2 years of age and older: apply to 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
​warnings (​Warnings)

​For external use only.

​flammable: (​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 inhailing contents can be harmful or fatal.

​questions? (​Questions?)

Call 1-866-964-0939

Active Ingredient (Active ingredient)

Calamine 8%

Pramoxine HCl 1%

​other Information (​Other information)

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

Principal Display Panel

Premier

solutions



NO-RUB

CALAMINE

PLUS SPRAY

CALAMINE 8% / SKIN PROTECTANT

PRAMOXINE HCL 1% / EXTERNAL ANALGESIC

RELIEVES ITCHING FROM

POISON IVY, OAK & SUMAC,

PLUS INSECT BITES

Soothes minor skin irritations & cuts



SHAKE WELL!



NET WT. 4.1 OZ. (116g)

​inactive Ingredients (​Inactive ingredients)

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

​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
  • symtomps 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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