Skip to Content

← See all Calamine Phenolated Topical Suspension brands

Calamine Phenolated Topical Suspension

Dosage form: lotion
Ingredients: ZINC OXIDE 160mg in 1mL, PHENOL 10mg in 1mL
Labeler: Humco Holding Group, Inc
NDC Code: 0395-0407

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.

Calamine PhenolatedTopical Suspension USP

Drug Facts

Active Ingredient

Calamine 8%

Purpose

Skin Protectant

Active Ingredient

Zinc Oxide 8%

Purpose

Skin Protectant

Active Ingredient

Liquefied Phenol 1%

Purpose

Topical Analgesic

Uses

Dries the oozing and weeping and temporarily 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.
  • Do not apply to large areas of the body or in large quantities, particularly over raw or blistered areas.
  • If applied to fingers or toes do not bandage.

Ask a doctor

before using on children under 2 years of age.

When using this product. Discontinue use if condition worsen or does not improve within 7 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 (Shake well before using)

Adult and children 2 years of age and older: Cleanse the skin with soap and water and let dry before each use. Apply product to the affected area using cotton or soft cloth, as often as needed for comfort.

Children under 2 years of age: Consult a doctor before use.

Other Information.

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

Inactive Ingredients.

Bentonite Magma, Calcium Hydroxide, Glycerin, Purified Water.

Principal Display Panel

Label

CALAMINE PHENOLATED TOPICAL SUSPENSION 
calamine and zinc oxide and phenol lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0395-0407
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (ZINC CATION) ZINC CATION160 mg  in 1 mL
PHENOL (PHENOL) PHENOL10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENTONITE 
CALCIUM HYDROXIDE 
GLYCERIN 
WATER 
Packaging
#Item CodePackage Description
1NDC:0395-0407-96177 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34703/25/1998
Labeler - Humco Holding Group, Inc (825672884)
Registrant - Humco Holding Group, Inc. (825672884)
Establishment
NameAddressID/FEIOperations
Humco Holding Group, Inc.825672884manufacture(0395-0407), pack(0395-0407), analysis(0395-0407), label(0395-0407)

 
Humco Holding Group, Inc

← See all Calamine Phenolated Topical Suspension brands

Medically reviewed on Nov 13, 2017

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Hide