OTC Medication Information: Calaclear

CALACLEAR- pramoxine hydrochloride and zinc acetate lotion
Wal-Mart Stores, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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.

Ask a doctor before using

on children under 2 years of age.

When using this product . Discontinue 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 professional assistance or contact a Poison Control Center immediately.

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 (59 o – 86 o F)

Inactive Ingredient

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

Label

Equate Calaclear
(click image for full-size original)
Label
(click image for full-size original)

CALACLEAR
pramoxine hydrochloride and zinc acetate lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:49035-402
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PRAMOXINE HYDROCHLORIDE (PRAMOXINE) PRAMOXINE HYDROCHLORIDE 10 mg in 1 mL
ZINC ACETATE (ZINC CATION) ZINC CATION 1 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
ALCOHOL
CAMPHOR (NATURAL)
DIAZOLIDINYL UREA
GLYCERIN
HYPROMELLOSE, UNSPECIFIED
METHYLPARABEN
POLYSORBATE 80
PROPYLENE GLYCOL
PROPYLPARABEN
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49035-402-96 177 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part347 01/03/2018
Labeler — Wal-Mart Stores, Inc. (051957769)
Registrant — Humco Holding Group, Inc. (825672884)
Establishment
Name Address ID/FEI Operations
Humco Holding Group, Inc. 825672884 manufacture (49035-402), analysis (49035-402), pack (49035-402), label (49035-402)

Revised: 12/2021 Wal-Mart Stores, Inc.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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