Radiaderm System Kit (Dimethicone) Lotion [Water-Jel Technologies] -

RADIADERM SYSTEM KIT (DIMETHICONE) LOTION [WATER-JEL TECHNOLOGIES]
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Active ingredient

Dimethicone 2.0%
Purpose

Skin Protectant
Uses
- temporarily protects minor cuts, scrapes, burns
- helps prevent and temporarily protects and helps relieve chafed, chapped or cracked skin
Warnings
For external use only
Do not use on
- deep or puncture wounds
- animal bites
- serious burns
When using this product

do not get into eyes
Stop use and ask a doctor if
- condition worsens
- symptoms persist for more than 7 days or clear up and occur again within a few days
Keep out of the reach of children

If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- apply as needed
Other information
- store at 20 to 25 oC (68 to 77 oF)
Inactive ingredients

water, milk protein, caprylic/capric triglyceride, mineral oil, butylene glucol, cetearyl alcohol, glyceryl stearate, PEG-100 stearate, phenoxyethanol, ceteareth-20, triethanolamine, acrylates/C10-30 alkyl acrylate crosspolymer, allantoin, sodium phosphate, caprylyl glycol, chlorphenesin, dosodium phosphate, disodium EDTA
QUESTIONS

1-800-275-3433 info@waterjel.com www.waterjel.com
Principle Display Panel

INGREDIENTS AND APPEARANCE

RADIADERM SYSTEM KIT
dimethicone lotion

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	2 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
MINERAL OIL (UNII: T5L8T28FGP)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PEG-100 STEARATE (UNII: YD01N1999R)
TROLAMINE (UNII: 9O3K93S3TK)
ALLANTOIN (UNII: 344S277G0Z)
SODIUM PHOSPHATE (UNII: SE337SVY37)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
EDETATE DISODIUM (UNII: 7FLD91C86K)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:59898-122-30	66 in 1 BOX, UNIT-DOSE	02/01/2014	08/01/2018
1		3 g in 1 PACKET; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part332	02/01/2014

Labeler - Water-Jel Technologies (155522589)

Name	Address	ID/FEI	Business Operations
Establishment
Water-Jel Technologies		155522589	manufacture(59898-122)

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