DR BUTLER DIAPER RASH- dimethicone 1% cream 
Beyond Health P.A.

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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Dr. Butler Diaper Rash Cream

Dimethicone 1%

Skin Protectant

Helps treat and prevent diaper rash, protects minor skin irritation due to diaper rash and helps seal out wetness.

For external use only.

Do not use on deep or puncture wounds, animal bites, or serious burns.

When using this product avoid contact with eyes.

Stop use and ask a doctor if condition worsens, symptoms last more than 7 days or clear up and occur again within a few days.

If swallowed, seek medical help or contact a Poison Control Center immediately.

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.

Water, glycerin, petrolatum, panthenol, stearyl alcohol, steareth-20, isopropyl palmitate, cetyl alcohol, avena sativa (oat) kernel oil, sodium hyaluronate, hamamelis virginiana (witch hzael) leaf extract, rosmarinus officinalis (rosemary) leaf extract, claendula officinalis flower extract, chamomilla recutita (matricaria) flower extract, curcuma longa (tumeric) root extract, olea europaea (olive) leaf extract, lavandula angustifolia (lavender) flower extract, helichrysum italicum extract, centella asiatica extract, panax ginseng root extract, aesculus hippocastanum (horse chestnut) extract, melaleuca alternifolia (tea tree) leaf extract, carya ovata bark extract, avena sativa (oat) kernel extract, cucumis sativus (cucumber) fruit extract, sorbitol, lecithin, xanthan gum, oleic acid, iron oxides (CI 77491), phenoxyethanol, ethylhexylglycerin, sodium chloride, colloidal oatmeal, 4-t-butylcyclohexanol, pentylene glycol, benzalkonium chloride, ceramide NP.

Carton

DR BUTLER DIAPER RASH 
dimethicone 1% cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70942-259
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE 350 (UNII: 2Y53S6ATLU) (DIMETHICONE 350 - UNII:2Y53S6ATLU) DIMETHICONE 3501 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CETYL ALCOHOL (UNII: 936JST6JCN)  
SORBITOL (UNII: 506T60A25R)  
CARYA OVATA BARK (UNII: X765CF609L)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
OATMEAL (UNII: 8PI54V663Y)  
CUCUMBER (UNII: YY7C30VXJT)  
PETROLATUM (UNII: 4T6H12BN9U)  
GLYCERIN (UNII: PDC6A3C0OX)  
PANTHENOL (UNII: WV9CM0O67Z)  
4-TERT-BUTYLCYCLOHEXANOL (UNII: K0H1405S9C)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
CHAMOMILE (UNII: FGL3685T2X)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
STEARETH-20 (UNII: L0Q8IK9E08)  
WATER (UNII: 059QF0KO0R)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
HAMAMELIS VIRGINIANA LEAF (UNII: T07U1161SV)  
ROSEMARY (UNII: IJ67X351P9)  
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)  
OAT KERNEL OIL (UNII: 3UVP41R77R)  
LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)  
CENTELLA ASIATICA TRITERPENOIDS (UNII: 4YS74Q4G4J)  
ASIAN GINSENG (UNII: CUQ3A77YXI)  
HORSE CHESTNUT (UNII: 3C18L6RJAZ)  
MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ALKYL DIMETHYL BENZYL AMMONIUM CHLORIDE (C12-C16) (UNII: F5UM2KM3W7)  
CERAMIDE NP (UNII: 4370DF050B)  
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
HELICHRYSUM ITALICUM FLOWER (UNII: P62Y550X24)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
XANTHAN GUM (UNII: TTV12P4NEE)  
OLEIC ACID (UNII: 2UMI9U37CP)  
TURMERIC (UNII: 856YO1Z64F)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70942-259-0385 g in 1 CAN; Type 0: Not a Combination Product03/22/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM01603/22/2023
Labeler - Beyond Health P.A. (026781064)
Registrant - Derma Care Research Labs (116817470)
Establishment
NameAddressID/FEIBusiness Operations
Derma Care Research Labs116817470manufacture(70942-259)

Revised: 3/2023
Document Id: f78143d5-4249-1f13-e053-6294a90acf85
Set id: f78143d5-4248-1f13-e053-6294a90acf85
Version: 1
Effective Time: 20230322
 
Beyond Health P.A.