Active Ingredients And Purpose
Active Ingredient
Pramoxine HCl 1%
Purpose
External Analgesic
Active Ingredient
Zinc Acetate 0.1%
Purpose
Skin Protectant
Calaclear
- Manufacturer
- Pharma Nobis, LLC
- Effective date
- 2023-12-26
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-06-01 00:05:45
Key Label Information#
Uses
Use
Dries the oozing and weeping and temporarily relieves pain and itching of poison ivy, poison oak, and poison sumac or other minor skin irritations.
Warnings
Warnings
For external use only. Use only as directed. Avoid contact with eyes and mucous membranes.
Directions And Dosage
Directions
Adults and children 2 yrs. of age and older. Shake well before using. Cleanse the skin with soap and water and 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 under 2 years of age: Consult a doctor before use.
Other Label Information
Inactive Ingredient
SD Alcohol 38B 2.5%, Camphor, Diazolidinyl Urea, Fragrances, Glycerin, Hydroxypropyl Methylcellulose, Methylparaben, Polysorbate 80, Propylene Glycol, Propylparaben, Purified Water.
GNP Label
Leader Label
Quality Choice Label
Label Images#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1248193 | CALACLEAR 1 % / 0.1 % Topical Lotion | PSN | 2 |
| 1234546 | pramoxine HCl 1 % / zinc acetate 0.1 % Topical Lotion | PSN | 2 |
| 1248193 | pramoxine hydrochloride 10 MG/ML / zinc acetate 1 MG/ML Topical Lotion [Calaclear] | SBD | 2 |
| 1234546 | pramoxine hydrochloride 10 MG/ML / zinc acetate 1 MG/ML Topical Lotion | SCD | 2 |
| 1248193 | Calaclear (pramoxine hydrochloride 1 % / zinc acetate 0.1 % ) Topical Lotion | SY | 2 |
| 1234546 | pramoxine HCl 1 % / zinc acetate 0.1 % Topical Lotion | SY | 2 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| ZINC CATION Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 190f2a5b-bbc8-65c7-fcb0-97891307b917 | Product name | 1 | 20140508 |
| 58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8 | Product name | 1 | 20140508 |
| a7051cba-790b-a699-81f8-dbbbdbd9b5ac | Product name | 1 | 20140508 |
| da108d9e-edc8-17a3-8c28-3251c6a8accc | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 82645-923-96 | Calaclear | 177 mL in 1 BOTTLE, PLASTIC | LOTION | 177 | 2 |
DailyMed Dashboard NDC Coverage#
Products#
- Calaclear
- Pramoxine Hydrochloride and Zinc Acetate
- PRAMOXINE
- ZINC CATION
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 82645-923 | 82645-923-96 |
Ingredients#
| Name | UNII | Kind |
|---|---|---|
| ALCOHOL | 3K9958V90M | IACT |
| CAMPHOR (NATURAL) | N20HL7Q941 | IACT |
| DIAZOLIDINYL UREA | H5RIZ3MPW4 | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| HYPROMELLOSE, UNSPECIFIED | 3NXW29V3WO | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| POLYSORBATE 80 | 6OZP39ZG8H | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| PROPYLPARABEN | Z8IX2SC1OH | IACT |
| WATER | 059QF0KO0R | IACT |
| PRAMOXINE HYDROCHLORIDE | 88AYB867L5 | ACTIB |
| ZINC ACETATE | FM5526K07A | ACTIM |
Complete SPL Sections#
SPL UNCLASSIFIED SECTION
Humco Calamine Lotion Drug Facts
Active Ingredient
Pramoxine HCl 1%
Purpose
External Analgesic
Active Ingredient
Zinc Acetate 0.1%
Purpose
Skin Protectant
Use
Dries the oozing and weeping and temporarily relieves pain and itching of poison ivy, poison oak, and poison sumac or other minor skin irritations.
Warnings
For external use only. Use only as directed. Avoid contact with eyes and mucous membranes.
Directions
Adults and children 2 yrs. of age and older. Shake well before using. Cleanse the skin with soap and water and 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 under 2 years of age: Consult a doctor before use.
Other Information
store at room temperature 15 o – 30 o C (50 o – 85 o F)
Inactive Ingredient
SD Alcohol 38B 2.5%, Camphor, Diazolidinyl Urea, Fragrances, Glycerin, Hydroxypropyl Methylcellulose, Methylparaben, Polysorbate 80, Propylene Glycol, Propylparaben, Purified Water.