Private Label Calamine Phenolated Topical Suspension, Usp

Private Label Calamine Phenolated Topical Suspension, Usp
SPL v2
SPL
SPL Set ID e42fbdcc-3291-7761-e053-2995a90a7172
Route
TOPICAL
Published
Effective Date 2017-12-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Cation (160 mg) Phenol (10 mg)
Inactive Ingredients
Bentonite Calcium Hydroxide Glycerin Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2008-01-01

Description

Drug Facts

Purpose

Skin Protectant


Medication Information

Purpose

Skin Protectant

Description

Drug Facts

Uses

Dries the oozing and weeping and temporarily pain and itching of poison ivy, poison oak, and poison sumac, or other minor skin irritations

Section 42229-5

Drug Facts

Warnings
  • For external use only. Use only as directed.
  • Avoid contact with eyes and mucous membranes.
  • Do not apply to large areas of the body or in large quantities, particularly over raw or blistered areas.
  • If applied to fingers or toes do not bandage.
Ask A Doctor

before using on children under 2 years of age.

When using this product. Discontinue use if condition worsen or does not improve within 7 days and consult a doctor.

Sunmark Label

Active Ingredient

Calamine 8%

Other Information.

Store at room temperature 15-30C (59-86F)

Good Neighbor Label

Inactive Ingredients.

Bentonite Magma, Calcium Hydroxide, Glycerin, Purified Water.

Questions Or Comments?

1-800-662-3435  www.goodneighborpharmacy.com

Keep Out of Reach of Children.

In case of accidental ingestion, seek professional assistance or contact a poison Control Center immediately.

Directions (shake Well Before Using)

Adult and children 2 years of age and older: Cleanse the skin with soap and water and let dry before each use. Apply product to the affected area using cotton or soft cloth, as often as needed for comfort.

Children under 2 years of age: Consult a doctor before use.


Structured Label Content

Uses

Dries the oozing and weeping and temporarily pain and itching of poison ivy, poison oak, and poison sumac, or other minor skin irritations

Section 42229-5 (42229-5)

Drug Facts

Purpose

Skin Protectant

Warnings
  • For external use only. Use only as directed.
  • Avoid contact with eyes and mucous membranes.
  • Do not apply to large areas of the body or in large quantities, particularly over raw or blistered areas.
  • If applied to fingers or toes do not bandage.
Ask A Doctor (Ask a doctor)

before using on children under 2 years of age.

When using this product. Discontinue use if condition worsen or does not improve within 7 days and consult a doctor.

Sunmark Label

Active Ingredient

Calamine 8%

Other Information.

Store at room temperature 15-30C (59-86F)

Good Neighbor Label

Inactive Ingredients.

Bentonite Magma, Calcium Hydroxide, Glycerin, Purified Water.

Questions Or Comments? (Questions or Comments?)

1-800-662-3435  www.goodneighborpharmacy.com

Keep Out of Reach of Children. (Keep out of reach of children.)

In case of accidental ingestion, seek professional assistance or contact a poison Control Center immediately.

Directions (shake Well Before Using) (directions (Shake well before using))

Adult and children 2 years of age and older: Cleanse the skin with soap and water and let dry before each use. Apply product to the affected area using cotton or soft cloth, as often as needed for comfort.

Children under 2 years of age: Consult a doctor before use.


Advanced Ingredient Data


Raw Label Data

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