DIMETHICONE AND ZINC OXIDE - dimethicone and zinc oxide ointment 
CVS

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.

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drug facts

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

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

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

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

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

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 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


label
DIMETHICONE AND ZINC OXIDE 
dimethicone and zinc oxide ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-082
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE10 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE100 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59779-082-02113 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34706/01/2009
Labeler - CVS (062312574)
Registrant - Pharma Pac, LLC (140807475)
Establishment
NameAddressID/FEIBusiness Operations
Pharma Pac, LLC140807475manufacture

Revised: 2/2011
Document Id: 1d59fe5c-0280-435a-acb2-08bf20162755
Set id: c291d18d-0b53-4418-9047-a2f85c0f2621
Version: 3
Effective Time: 20110216
 
CVS