CALADROX- menthol, zinc oxide ointment

Caladrox by

Drug Labeling and Warnings

Caladrox by is a Otc medication manufactured, distributed, or labeled by Geritrex LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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)

DOSAGE & ADMINISTRATION

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CALADROX 
menthol, zinc oxide ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54162-229
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.44 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	20 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
LANOLIN (UNII: 7EV65EAW6H)
PHENOL (UNII: 339NCG44TV)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
THYMOL (UNII: 3J50XA376E)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
DMDM HYDANTOIN (UNII: BYR0546TOW)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
MINERAL OIL (UNII: T5L8T28FGP)
PETROLATUM (UNII: 4T6H12BN9U)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54162-229-04	113 g in 1 TUBE; Type 0: Not a Combination Product	09/29/2015

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	Business Operations
Geritrex LLC		112796248	manufacture(54162-229)