DIMETHICONE AND ZINC OXIDE ointment

DIMETHICONE and ZINC OXIDE by

Drug Labeling and Warnings

DIMETHICONE and ZINC OXIDE by is a Otc medication manufactured, distributed, or labeled by CVS, Pharma Pac, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients                       Purpose
Dimethicone 1%........................Diaper rash cream
Zinc Oxide 10%........................Diaper rash cream

PURPOSE

Active ingredients                       Purpose
Dimethicone 1%........................Diaper rash cream
Zinc Oxide 10%........................Diaper rash cream

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical
help or contact a Poison Control Center right away.

INDICATIONS & USAGE

Uses
- helps treat and prevent diaper rash
- protects minor skin irritation due to diaper rash and
helps seal out wetness

WARNINGS

Warnings
For external use only.

When using this product
- do not get into eyes

Stop use and ask a doctor if:
- condition worsens
- symptoms last more than 7 days or clear up and
occur again within several days

DOSAGE & ADMINISTRATION

Directions
- change wet and soiled diapers promptly
- cleanse the diaper area and allow to dry
- apply cream liberally as often as necessary with
each diaper change, especially at bedtime or anytime
when exposure to wet diapers may be prolonged

Other information
Store between 20 degrees to 25 degrees C (68 degrees to 77 degrees F)

INACTIVE INGREDIENT

Inactive Ingredients aloe barbadensis extract,
benzyl alcohol, coconut oil, cod liver oil (contains
vitamin A and vitamin D), fragrance, glyceryl oleate, light
mineral oil, ozokerite, paraffin, propylene glycol,
sorbitol, synthetic beeswax, water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DIMETHICONE AND ZINC OXIDE 
dimethicone and zinc oxide ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59779-082
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	10 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	100 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
MINERAL OIL (UNII: T5L8T28FGP)
COCONUT OIL (UNII: Q9L0O73W7L)
COD LIVER OIL (UNII: BBL281NWFG)
GLYCERYL MONOOLEATE (UNII: 4PC054V79P)
PARAFFIN (UNII: I9O0E3H2ZE)
CERESIN (UNII: Q1LS2UJO3A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WHITE WAX (UNII: 7G1J5DA97F)
BENZYL ALCOHOL (UNII: LKG8494WBH)
ALOE (UNII: V5VD430YW9)
SORBITOL (UNII: 506T60A25R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59779-082-02	113 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	06/01/2009

Labeler - CVS (062312574)

Registrant - Pharma Pac, LLC (140807475)

Establishment
Name	Address	ID/FEI	Business Operations
Pharma Pac, LLC		140807475	manufacture