Caldyphen Clear

Caldyphen Clear
SPL v3
SPL
SPL Set ID d8802e56-649e-4494-86ee-7ca8841cc28b
Route
TOPICAL
Published
Effective Date 2013-06-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Pramoxine (10 mg) Zinc Cation (1 mg)
Inactive Ingredients
Camphor (natural) Diazolidinyl Urea Glycerin Hypromellose, Unspecified Methylparaben Polysorbate 80 Propylene Glycol Propylparaben Water

Identifiers & Packaging

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

Description

Drug Facts

Purpose

External analgesic


Medication Information

Purpose

External analgesic

Description

Drug Facts

Uses

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

Section 42229-5

Drug Facts

Directions

Adults and children 2 yrs. of age and older. Shake well before using. cleanse the skin with soap and water. Let dry before each use. apply lotion to the affected area using cotton or soft cloth, not more than 3 to 4 times daily as needed for comfort.

children unedr 2 yrs. of age. Consult a doctor before use.

Warnings 

For External Use Only. Use only as directed. Avoid contact with eye and mucous membranes. ask a doctor before using on children under 2 years of age.

Active Ingredient

Pramoxine HCl 1%

Other Information

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

Inactive Ingredients

SD alcohol 38B 2.5%, Camphor, Diazolidinyl Urea, Fragrances, Glycerin, Hydroxypropyl Methylcellulose, Methylparaben, Polysorbate 80, Propylene Glycol, Propylparaben, and Purified Water.

Questions Or Comments?

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

Principal Display Panel

Stop Use and As A Doctor If

condition worsens. Symptoms last for more than 7 days or celar up and occur again whitin a few days.

Keep Out of Reach of Children

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


Structured Label Content

Uses

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

Section 42229-5 (42229-5)

Drug Facts

Purpose

External analgesic

Directions

Adults and children 2 yrs. of age and older. Shake well before using. cleanse the skin with soap and water. Let dry before each use. apply lotion to the affected area using cotton or soft cloth, not more than 3 to 4 times daily as needed for comfort.

children unedr 2 yrs. of age. Consult a doctor before use.

Warnings 

For External Use Only. Use only as directed. Avoid contact with eye and mucous membranes. ask a doctor before using on children under 2 years of age.

Active Ingredient

Pramoxine HCl 1%

Other Information (Other information)

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

Inactive Ingredients

SD alcohol 38B 2.5%, Camphor, Diazolidinyl Urea, Fragrances, Glycerin, Hydroxypropyl Methylcellulose, Methylparaben, Polysorbate 80, Propylene Glycol, Propylparaben, and Purified Water.

Questions Or Comments? (Questions or comments?)

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

Principal Display Panel

Stop Use and As A Doctor If (Stop use and as a doctor if)

condition worsens. Symptoms last for more than 7 days or celar up and occur again whitin a few days.

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.


Advanced Ingredient Data


Raw Label Data

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