FOSTER AND THRIVE CALDYPHEN- calamine and pramoxine hydrochloride lotion

Foster and Thrive Caldyphen by

Drug Labeling and Warnings

Foster and Thrive Caldyphen by is a Otc medication manufactured, distributed, or labeled by Strategic Sourcing Services, LLC, Pharma Nobis, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

Calamine 8%

Pramoxine HCl 1%

Purpose

Skin Protectant

External analgesic

Uses

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

Warnings

For external use only. Use only as directed.

When using this product. Avoid contact with eyes and moucous membranes.

When using this product

do not use if condition worsens, does not improve or if symptoms persist for more than 7 days or clear up and occur again within a few days, and consult a doctor.

Keep out of reach of children.

In case of accidental ingestion, seek profesional assistance or contact a Poison Control Center immediately. (1-800-222-1222)

Directions

Adults and children 2 yr. of age and older. Shake well before using. Cleanse the skin with soap and water and let dry. Apply to the affected area using cotton or soft cloth, not more than 3 to 4 times daily as needed for comfort.

Children under 2 yrs. of age. Consult a doctor before use.

Inactive Ingredients

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

Other information

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

SPL UNCLASSIFIED SECTION

Distributed by: McKesson Corp.

SSSL., Memphis, TN 38141

Questions?

Call 833-358-6431

Principal Display Panel

INGREDIENTS AND APPEARANCE

FOSTER AND THRIVE CALDYPHEN 
calamine and pramoxine hydrochloride lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70677-1198
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	80 mg  in 1 mL
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)	PRAMOXINE HYDROCHLORIDE	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CAMPHOR (NATURAL) (UNII: N20HL7Q941)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
GLYCERIN (UNII: PDC6A3C0OX)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70677-1198-1	177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/18/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	12/18/2024

Labeler - Strategic Sourcing Services, LLC (116956644)

Registrant - Pharma Nobis, LLC (118564114)