Foster & Thrive Caldyphen Lotion

Manufacturer
Strategic Sourcing Services, LLC | Pharma Nobis, LLC
Effective date
2024-12-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:44:34

Label at a glance#

ProductFoster and Thrive Caldyphen
Active ingredientZINC OXIDE, PRAMOXINE HYDROCHLORIDE
Label structure13 sections

Indications and uses

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

Dosage and administration

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.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Calamine 8%

Pramoxine HCl 1%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

External analgesic

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only. Use only as directed.

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

When using this product

OTC - WHEN USING SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

INACTIVE INGREDIENT SECTION

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

Other information

OTHER SAFETY INFORMATION

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

SPL UNCLASSIFIED SECTION

Distributed by: McKesson Corp.

SSSL., Memphis, TN 38141

Questions?

OTC - QUESTIONS SECTION

Call 833-358-6431

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FT Caldyphen LotionFT Caldyphen Lotion

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1234532calamine 8 % / pramoxine HCl 1 % Topical LotionPSN1
1234532calamine 80 MG/ML / pramoxine hydrochloride 10 MG/ML Topical LotionSCD1
1234532calamine 8 % / pramoxine hydrochloride 1 % Topical LotionSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70677-1198-1Foster and Thrive Caldyphen177 mL in 1 BOTTLE, PLASTICLOTION1771

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70677-1198FOSTER AND THRIVE CALDYPHEN (CALAMINE AND PRAMOXINE HYDROCHLORIDE) LOTION [STRATEGIC SOURCING SERVICES, LLC]1Current NDC, 1 package rows20241220_29945734-4ea6-b702-e063-6294a90ae6f2.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70677-1198-1ML - Milliliter70677-1198f231b169-e17a-4171-816b-c594b4c9b8c112025-01-14

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70677-119870677-1198-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Foster and Thrive CaldyphenCALAMINE AND PRAMOXINE HYDROCHLORIDEStrategic Sourcing Services, LLC29945734-4ea6-b702-e063-6294a90ae6f22024-12-18WarningsExact identifier
ndc (package): 70677-1198-1
ndc (product): 70677-1198
ndc11 (package): 70677119801
spl id: 29945218-aa80-7a4e-e063-6394a90acf67
spl set id: 29945734-4ea6-b702-e063-6294a90ae6f2

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.