MOISTURIZING CREAM- dimethicone lotion

Moisturizing Cream by

Drug Labeling and Warnings

Moisturizing Cream by is a Otc medication manufactured, distributed, or labeled by R & R Lotion, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

Dimethicone 4.0%

Purpose

Skin Protectant

Uses

Skin protectant, temporarily protects against harmful Pathogens & Stimuli while moisturizing dry and cracked hands.

Warnings

For external use only

• When using this product, aviod contact with eyes
• In case of eye contact, flush with water

• Keep out of reach of children, except under adult supervision
• If swallowed, get medical help

• Discontinue use if skin irritation or redness develops.

Directions

Rub into hands and body until absorbed.

Ingredients

DI Water, Octyl Palmitate, Corn Oil, Dimethicone, Polawax, Grape Seed Oil, Sunflower Butter, Glycerin, Cetyl Alcohol, Geogard Ultra, Triethanolamine 85, Carbopol 941, Aloe Vera, Jojoba, Blue Agave, Cranberry, Strawberry, Raspberry, Pomegranate, Green Tea, Green Coffee Bean, Grape Seed, Blueberry, Acai Berry, Vitamins A, D and E

Questions or Comments?

Call (480) 443-9255 or visit RRlotion.com

PRINCIPAL DISPLAY PANEL - 236 ML Bottle Label

R&R LOTION®
MOISTURIZING CREAM™

HAND CREAM

8 FL. OZ. (236ML) e

INGREDIENTS AND APPEARANCE

MOISTURIZING CREAM 
dimethicone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59555-801
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O)	Dimethicone	40 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Glycerin (UNII: PDC6A3C0OX)
Corn Oil (UNII: 8470G57WFM)
Gluconolactone (UNII: WQ29KQ9POT)
Sodium Benzoate (UNII: OJ245FE5EU)
Calcium Gluconate (UNII: SQE6VB453K)
Carbomer Homopolymer Type A (Allyl Pentaerythritol Crosslinked) (UNII: F68VH75CJC)
Ethylhexyl Palmitate (UNII: 2865993309)
Grape Seed Oil (UNII: 930MLC8XGG)
Cetyl Alcohol (UNII: 936JST6JCN)
.Alpha.-Tocopherol (UNII: H4N855PNZ1)
Trolamine (UNII: 9O3K93S3TK)
vitamin A (UNII: 81G40H8B0T)
cholecalciferol (UNII: 1C6V77QF41)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59555-801-08	236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part347	12/21/2015

Labeler - R & R Lotion, Inc (062979000)