R2 SKIN PROTECTANT- dimethicone lotion

R2 Skin Protectant by

Drug Labeling and Warnings

R2 Skin Protectant by is a Otc medication manufactured, distributed, or labeled by Water-Jel Technologies. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

R2 SKIN PROTECTANT 
dimethicone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59898-121
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 g

Inactive Ingredients
Ingredient Name	Strength
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)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59898-121-46	3 g in 1 PACKET; Type 0: Not a Combination Product	02/01/2014	08/01/2018
2	NDC: 59898-121-47	10 in 1 BOX, UNIT-DOSE	02/01/2014	08/01/2018
2		3 g in 1 PACKET; Type 0: Not a Combination Product
3	NDC: 59898-121-48	66 in 1 BOX, UNIT-DOSE	02/01/2014	08/01/2018
3		3 g in 1 PACKET; Type 0: Not a Combination Product

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

Labeler - Water-Jel Technologies (155522589)

Establishment
Name	Address	ID/FEI	Business Operations
Water-Jel Technologies		155522589	manufacture(59898-121)