OTC Medication Information: Caladrox

CALADROX- menthol and zinc oxide ointment
Geritrex 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.

Drug Facts

Active Ingredient: Purpose:

Menthol 0.44% External analgesic

First aid antiseptic / antipruritic

Zinc Oxide 20.0% Skin protectant / moisture barrier

Uses

A moisture barrier that prevents and helps heal skin irritation from Urine, diarrhea, perspiration, fistula drainge, feeding tube site leakage, wound drainage (peri-wound skin), minor burns, cuts, scrapes, itching

Directions

Cleanse skin gently with mild skin cleanser. Pat dry or allow to air dry. Apply a thin layer of Caladrox Ointment to reddened or irritated skin 2-4 times daily or after each incontinent episode or diaper change to promote comfort and long lasting protection

Warnings

FOR EXTERNAL USE ONLY

Not for deep or puncture wounds

Avoid contact with eyes

If condition worsens or does not improve within 7 days, consult a doctor

Inactive Ingredients

Calamine, DMDM Hydantoin, Glycerin, Lanolin, Methylparaben, Mineral Oil, Petrolatum, Phenol, Propylparaben, Propylene Glycol, Purified Water, Sodium Laureth Sulfate, Stearyl Alcohol, Sorbitan Sesquioleate, Sodium bicarbonate and Thymol

KEEP OUT OF REACH OF CHILDREN

In the event of accidental ingestion contact a Poison Control Center right away

Storage

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

Apply a thin layer of Caladrox Ointment to reddened or irritated skin 2-4 times daily.

Label of Tube
(click image for full-size original)

CALADROX
menthol, zinc oxide ointment
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:54162-229
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MENTHOL (MENTHOL) MENTHOL 0.44 g in 100 g
ZINC OXIDE (ZINC CATION) ZINC CATION 20 g in 100 g
Inactive Ingredients
Ingredient Name Strength
GLYCERIN
LANOLIN
PHENOL
SODIUM BICARBONATE
THYMOL
SODIUM LAURETH SULFATE
METHYLPARABEN
PROPYLPARABEN
DMDM HYDANTOIN
STEARYL ALCOHOL
PROPYLENE GLYCOL
SORBITAN SESQUIOLEATE
MINERAL OIL
PETROLATUM
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54162-229-04 113 g in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part347 09/29/2015
Labeler — Geritrex LLC (112796248)
Registrant — Geritrex LLC (112796248)
Establishment
Name Address ID/FEI Operations
Geritrex LLC 112796248 manufacture (54162-229)

Revised: 09/2015 Geritrex 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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