Topcare Calamine Plus Spray

SPL v11

SPL

SPL Set ID af314adb-bd65-4233-b7e1-6cfb819615a3

Route

TOPICAL

Published

Effective Date 2017-12-02

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Ferric Oxide Red (0.345 mg) Zinc Cation (24.16 mg) Pramoxine (2.72 mg)

Inactive Ingredients

Benzyl Alcohol Camphor (synthetic) Disteardimonium Hectorite Hydrated Silica Isobutane Oleyl Alcohol Alcohol Sorbitan Trioleate

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2017-01-01

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

Warnings

For external use only. Use only as directed. Intentional misuse by deliberately concentrating and inhailing contents can be harmful or fatal.

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

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)

Inactive Ingredients

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

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)

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

Purpose

Skin protectant

External analgesic

Warnings

For external use only. Use only as directed. Intentional misuse by deliberately concentrating and inhailing contents can be harmful or fatal.

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

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)

Inactive Ingredients (Inactive ingredients)

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

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)

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

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Raw Label Data

All Sections (JSON)

{"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", "Warnings": "For external use only. Use only as directed. Intentional misuse by deliberately concentrating and inhailing contents can be harmful or fatal.", "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", "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)", "Inactive ingredients": "benzyl alcohol, camphor, disteardimonium hectorite, fragrance, hydrated silica, isobutane, oleyl alcohol, SD alcohol 40-B, sorbitan trioleate", "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)", "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."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:45.840972 · Updated: 2026-03-14T23:13:28.374847