Calamine
Equaline 336.003/336AG Medicated Calamine Lotion
0bc1a9b4-1210-4d9a-bbd2-40e9225e86ea
HUMAN OTC DRUG LABEL
Jun 2, 2025
United Natural Foods, Inc. dba UNFI
DUNS: 943556183
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Calamine, Pramoxine HCl
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (13)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Principal display panel
Compare to Caladryl ®Lotion active ingredient*
NDC 41163-536-30
EQUALINE ®
medicated calamine lotion
external analgesic
skin protectant
drying action plus itch relief
6 FL OZ (177 mL)
INDICATIONS & USAGE SECTION
Use
- for the temporary relief of pain and itching associated with minor skin irritations and rashes due to poison ivy, poison oak, or poison sumac
- dries the oozing and weeping of poison:
- ivy
- oak
- sumac
ADVERSE REACTIONS SECTION
ADVERSE REACTION
DISTRIBUTED BY UNFI
PROVIDENCE, RI 02908 USA
855-423-2630
DOSAGE & ADMINISTRATION SECTION
Directions
- shake well
- before applying was affected are of skin
Adults and children 2 years of age and older - apply to affected area not more than 3 to 4 times daily
Children under 2 years of age - do not use, ask a doctor
OTC - STOP USE SECTION
Stop use and ask a doctor
- condition worsens
- symptoms last more than 7 days or clear up and occur again within a few days
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
OTC - ACTIVE INGREDIENT SECTION
Active ingredients
Calamine 8%
Pramoxine HCl 1%
OTC - PURPOSE SECTION
Purpose
Skin protectant
External analgesic
WARNINGS SECTION
Warnings
For external use only
OTC - WHEN USING SECTION
When using this product
- do not get into eyes
SPL UNCLASSIFIED SECTION
Disclaimer
*This product is not manufactured or distributed by Bausch Health US, LLA, distributor of Caladryl Lotion Calamine Plus Itch Reliever.
INACTIVE INGREDIENT SECTION
Inactive ingredients
alcohol, benzyl alcohol, camphor, fragrance, hydroxypropyl methylcellulose, Lavandula angustifolia (lavender) oil, phenoxyethanol, polysorbate 80, propylene glycol, Rosmarinus officinalis (rosemary) leaf oil, water, xanthan gum