OTC Medication Information: Calamine

CALAMINE- ferric oxide red and pramoxine hydrochloride lotion
Meijer Distribution

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

External analgesic

Use

  • for the temporary relief of pain and itching associated with minot skin irritations and rashes due to poison ivy, poison oak, or poison sumac
  • dries the oozing and weeping of poison:
  • ivy
  • oak
  • sumac

Warnings

For external use only

When using this product

  • do not get into eyes

Stop use and ask a doctor

  • condition worsens
  • symptoms last more than 7 days or clean 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 applying was affected are of skin

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 — do not use, ask a doctor

Other information

store at room temperature (59°-77°F)

Inactive ingredients

alcohol, camphor, diazolidinyl urea, fragrance, hypromellose, methylparaben, oil of lavender, oil of rosemary, polysorbate 80, propylene glycol, propylparaben, purified water, xanthan gum

*This product is not manufactured or distributed by Valeant Pharmaceuticals, distributor of Caladryl Lotion

DIST. BY MEIJER

DISRIBUTION, INC

GRAND RAPIDS, MN 49544

www.meijer.com

principal display panel

NDC 41250-888-30

Compare to Caladryl Lotion

Meijer

MEDICATED

calamine lotion

External Analgesic/Skin Protectant

Drying Action Plus Itch Relief

Relieves itching due to insect bites, poison oak or ivy, or other minor skin irritation

6 FL OZ (177 mL)

image description
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CALAMINE
calamine, pramoxine hcl lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:41250-888
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
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 (SYNTHETIC)
DIAZOLIDINYL UREA
HYPROMELLOSES
METHYLPARABEN
LAVENDER OIL
ROSEMARY OIL
POLYSORBATE 80
PROPYLENE GLYCOL
PROPYLPARABEN
WATER
XANTHAN GUM
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:41250-888-30 177 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 06/17/2009
Labeler — Meijer Distribution (006959555)
Registrant — Vi-Jon, LLC (790752542)
Establishment
Name Address ID/FEI Operations
Vi-Jon, LLC 790752542 manufacture (41250-888)
Establishment
Name Address ID/FEI Operations
Vi-Jon, LLC 088520668 manufacture (41250-888)

Revised: 01/2023 Meijer Distribution

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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