Active ingredient

Dimethicone 5% w/w

Zinc oxide 5% w/w

Purpose

Skin protectant

Uses

helps treat and prevent diaper rash
protects minor skin irritation associated with diaper rash and helps seal out wetness

Warnings

For external use only.

Do not use

on deep or puncture wounds
on animal bites
on serious burns

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 a few days

Keep out of reach of children.

If swallowed, get medical help or consult a Poison Control Center right away.

Directions

change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry
apply product 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 at 15°C-30°C (59°F-86°F)
*for infacts/neonates, please use under medical supervision

Inactive ingredients

butylene/ethylene/styrene copolymer, calamine, carthamus tinctorius (safflower) oleosomes, cellulose gum, cocos nucifera (coconut) oil, ethylene/propylene/styrene copolymer, gelatin, gossypium herbaceum (cotton) seed oil, hydrolyzed collagen, lanolin, microcrystalline wax, mineral oil, oleic acid, pectin, phenoxyethanol, punica granatum sterols, simmondsia chinensis (jojoba) seed oil, sodium hyaluronate, steric acid, theobroma cacao (cocoa) seed butter, tocopheryl acetate, water

Manufacturing Information

Manufactured for Medline Industries, LP

Three Lakes Drive, Northfiels, IL 60093 USA

Made in USA of foreign and domestic materials

www.medline.com

1-800-MEDLINE

REF: 413586

V1 RE21AXQ

Package Label

SENSI-CARE
dimethicon, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:53329-769
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	5 g in 100 g
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	5 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
OLEIC ACID (UNII: 2UMI9U37CP)
PUNICA GRANATUM STEROLS (UNII: UKV92KC49T)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
FERRIC OXIDE RED (UNII: 1K09F3G675)
CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
LEVANT COTTONSEED OIL (UNII: N5CFT140R8)
STEARIC ACID (UNII: 4ELV7Z65AP)
COCOA BUTTER (UNII: 512OYT1CRR)
COCONUT OIL (UNII: Q9L0O73W7L)
LANOLIN (UNII: 7EV65EAW6H)
PECTIN (UNII: 89NA02M4RX)
JOJOBA OIL (UNII: 724GKU717M)
MINERAL OIL (UNII: T5L8T28FGP)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:53329-769-14	56 g in 1 TUBE; Type 0: Not a Combination Product	09/30/2020	12/31/2024
2	NDC:53329-769-64	141 g in 1 TUBE; Type 0: Not a Combination Product	09/30/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	M016	09/30/2020

Labeler - Medline Industries, LP (025460908)

Registrant - Medline Industries, LP (025460908)

769 Sensi-Care Clear Zinc