Label: ATTENDS DAILY BARRIER- dimethicone, zinc oxide spray
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Contains inactivated NDC Code(s)
NDC Code(s): 62450-001-01 - Packager: Purna Pharmaceuticals NV
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated March 6, 2014
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
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PURPOSE
Attends Professional Care
Prevents. Treats. Protects. 3in1
Attends Daily Barrier S[ray
Zinc Oxide & Dimethicone Skin Protectant
Gentle enough for daily use
Convenient and easy to use Pump Spray
- No rubbing
- No staining
- No stinging
(Spanish Panel)
- Prevents diaper rash
- Treats irritated, chafed skin
- Provides protective barrier to help keep skin drier
(Spanish Section
Dermatologically Tested
Net Wt. 3.5 oz (99.2 g)
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
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DOSAGE & ADMINISTRATION
Directions
- Cleanse the diaper area and allow to dry
- Shake bottle well before every use
- Change wet and soiled diapers promptly
- Spray 4-6 inches from skin. No rub in is required
- Apply product liberally as often as necessary, with each dipaer change, especially at bedtime or any time exposure to wet diapers may be prolonged
- OTHER SAFETY INFORMATION
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INACTIVE INGREDIENT
Inactive Ingredients
aloe barbadensis gel, aqua, C12-15 alkyl benzoate, dimethicone, glyceryl stearate, L-Carnoside, methylparaben, microcrystalline cellulose, panthenol, paraffinum liquidum, parfum, PEG-100 stearate, propylene glycol, propylparaben, prunus amygdalus dulcis oil, sorbitan stearate, tocopherol, zinc oxide.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ATTENDS DAILY BARRIER
dimethicone, zinc oxide sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62450-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 4 g in 99 g DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 2 g in 99 g Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) WATER (UNII: 059QF0KO0R) C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) CARNOSINE (UNII: 8HO6PVN24W) METHYLPARABEN (UNII: A2I8C7HI9T) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) PANTHENOL (UNII: WV9CM0O67Z) MINERAL OIL (UNII: T5L8T28FGP) PEG-100 STEARATE (UNII: YD01N1999R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) ALMOND OIL (UNII: 66YXD4DKO9) SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X) TOCOPHEROL (UNII: R0ZB2556P8) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62450-001-01 99 g in 1 PACKAGE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 03/06/2014 Labeler - Purna Pharmaceuticals NV (372126946) Establishment Name Address ID/FEI Business Operations Purna Pharmaceuticals NV 372126946 manufacture(62450-001)