TENDER MOMENTS DELICATE BABY DIAPER RASH BALM- dimethicone,zinc oxide cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O), ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)

Available from:

Jafra Cosmetics International, Inc.

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Skin Protectant ▪ Helps treat and prevent diaper rash ▪ Protects chafed skin due to diaper rash and helps seal out wetness

Authorization status:

OTC monograph final

Summary of Product characteristics

TENDER MOMENTS DELICATE BABY DIAPER RASH BALM- DIMETHICONE,ZINC
OXIDE CREAM
JAFRA COSMETICS INTERNATIONAL, INC.
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TENDER MOMENTS DELICATE BABY DIAPER RASH BALM
_ACTIVE INGREDIENTS_
Dimethicone 2.0%, Zinc Oxide 10.0%
_PURPOSE_
Skin Protectant
_USES_
▪ Helps treat and prevent diaper rash
▪ Protects chafed skin due to diaper rash and helps seal out wetness
_WARNINGS_
FOR EXTERNAL USE ONLY
WHEN USING THIS PRODUCTdo 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 in a
few days
KEEP OUT OF REACH OF CHILDREN.If swallowed, get medical help or
contact a Poison
Control Center right away.
_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
_INACTIVE INGREDIENTS_
Water/Aqua, Petrolatum, Isopropyl Palmitate, Diisostearoyl
Polyglyceryl-3 Dimer
Dilinoleate, Ethylhexyl Stearate, Cetyl Dimethicone, Magnesium
Sulfate, Beeswax/Cera
Alba, Butyrospermum Parkii (Shea Butter), Panthenol, Butylene Glycol,
Avena Sativa
(Oat) Kernel Extract, DMDM Hydantoin, Glycine Soja (Soybean) Oil, Aloe
Barbadensis Oil
PRODUCT LABEL
TENDER MOMENTS DELICATE BABY DIAPER RASH BALM
dimethicone,zinc oxide cream
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:68828-700
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)
DIMETHICONE
2 g in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)
ZINC CATION
10 g in 100 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
WATER (UNII: 059QF0KO0R)
PETROLATUM (UNII: 4T6H12BN9U)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
DIISOSTEAROYL POLYGLYCERYL-3 DIMER DILINOLEATE (UNII: G3232Z5S2O)
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)
CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)
MAGNESIUM SULFAT