OTC Medication Information: Calamine

CALAMINE- zinc oxide, ferric oxide red and pramoxine hydrochloride lotion
Navarro Discount Pharmacies, LLC

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.

Active ingredients

Calamine 8%

Pramoxine HCl 1%

Purpose

Skin protectant

Topical analgesic

Uses

temporarily relieves pain and itching associated with:

  • rashes due to poison ivy, poison oac or poison sumac
  • insect bites
  • minor skin irritation
  • minor cuts

dries the oozing and weeping of poison ivy, poison oak and poison sumac

Warnings

For external use only.

When using this product

do not get into eyes

Stop use and ask a doctor if

  • condition worsens or does not improve within 7 days
  • symptoms persist for more than 7 days or clear up and occur again within a few days

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • shake well before use
  • 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: ask a doctor

Other information

  • store at 20° to 25°C (68° to 77°F)

Inactive ingredients

SD alcohol 38-B, camphor, diazolidinyl urea, fragrance, hypromellose, methylparaben, polysorbate 80, propylene glycol, propylparaben, purified water, zanthan gum

Package Label

image of bottle label
(click image for full-size original)

CALAMINE
zinc oxide, ferric oxide red, pramozine hcl lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:59970-075
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 80 mg in 1 mL
FERRIC OXIDE RED (FERRIC OXIDE RED) FERRIC OXIDE RED 80 mg in 1 mL
PRAMOXINE HYDROCHLORIDE (PRAMOXINE) PRAMOXINE HYDROCHLORIDE 10 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
ALCOHOL
CAMPHOR (NATURAL)
HYPROMELLOSES
METHYLPARABEN
POLYSORBATE 80
PROPYLENE GLYCOL
PROPYLPARABEN
WATER
XANTHAN GUM
Product Characteristics
Color pink Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59970-075-01 177 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part347 06/03/2013
Labeler — Navarro Discount Pharmacies, LLC (094930963)
Registrant — Kareway Product, Inc. (121840057)

Revised: 05/2013 Navarro Discount Pharmacies, LLC

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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