Calamine Plus Pramoxine HCl
Caring Mills Calamine Plus Spray
3cd18f96-34f7-3f2c-e063-6294a90a3b7e
HUMAN OTC DRUG LABEL
Aug 19, 2025
FSA Store Inc.
DUNS: 049283340
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Calamine Plus Spray
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (11)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Principal Display Panel
Compare to the active
ingredients in Caladryl Lotion
caring mill
No-Rub
Calamine
Plus Spray
Calamine 8% / Skin Protectant
Pramoxine HCL 1% / External Analgesic
- Relieves itching from poison ivy,
oak & sumac, & insect bites
- Soothes minor skin
irritations & cuts
Shake Well Before Use
NET WT. 4.1 OZ. (116 g)
INDICATIONS & USAGE SECTION
Uses
temporarily relieves pain and itching associated with:
- insect bites
- rashes
- minor skin irritations
- minor cuts
- dries the oozing and weeping of poison ivy, poison oak and poison sumac
OTC - ACTIVE INGREDIENT SECTION
Active ingredient
Calamine 8%
Pramoxine HCl 1%
OTC - PURPOSE SECTION
Purpose
Skin protectant
External analgesic
INACTIVE INGREDIENT SECTION
Inactive ingredients
benzyl alcohol, camphor, disteardimonium hectorite, fragrance, hydrated silica, isobutane, oleyl alcohol, SD alcohol 40-B, sorbitan trioleate
OTC - QUESTIONS SECTION
Questions?
Call 1-866-964-0939
RECENT MAJOR CHANGES SECTION
WARNINGS SECTION
Warnings
For external use only.
Flammable:
Do not use while smoking or near heat or flame. Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120°F. Intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal.
When using this product
- do not get into eyes
- ask a doctor before using on children under 2 years of age
Stop use and ask a doctor if
- conditions worsens
- symptoms last more than 7 days or clear up and occur again in a few days
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
DOSAGE & ADMINISTRATION SECTION
Directions
- shake well before using
- adults and children 2 years of age and older: apply to affected area not more than 3 or 4 times daily
- cleanse the skin with soap and water
- let dry before use
- children under 2 years of age: consult a doctor
OTHER SAFETY INFORMATION
Other information
store between 20° to 25°C (68° to 77°F)