RAPID REPAIR HEALING CREAM- allantoin, dimethicone cream

Rapid Repair Healing Cream by

Drug Labeling and Warnings

Rapid Repair Healing Cream by is a Otc medication manufactured, distributed, or labeled by June Jacobs Labs LLC, June Jacobs Labs, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients

Allantoin- 0.50%

Dimethicone- 1.50%

PURPOSE

Active Ingredient ...............................Purpose

Allantoin 0.50%...................................Skin protectant

Dimethicone 1.50%............................Skin protectant

INDICATIONS & USAGE

Uses

• temporarily protects and helps relieve chapped or cracked skin.
• Helps protect from the drying effects of wind and cold weather.

WARNINGS

Warnings For external use only.

WHEN USING

When Using this product

• Keep out of the eyes. Rinse with water to remove.

ASK DOCTOR

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.

DO NOT USE

Do not use on

• deep or puncture wounds
• animal bites
• serious burns

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

if swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions

• Apply as needed

OTHER SAFETY INFORMATION

Other information:

• Store at 20-25C (68-77F)

INACTIVE INGREDIENT

Inactive Ingredients

Water/Aqua/Eau,
Stearic Acid, Glycerin, Caprylic/Capric Triglyceride, C12-15 Alkyl Benzoate, Glyceryl Stearate, Glyceryl Stearate Se, Cetearyl Alcohol, Fragrance/Parfum, Caprylyl Glycol, Squalane, Ceramide Np, Leuconostoc/Radish Root Ferment Filtrate, Leontopodium Alpinum Flower/Leaf Extract, Avena Sativa (Oat) Kernel Flour,Phytosteryl Canola Glycerides, Argania Spinosa (Argan) Kernel Oil, Butyrospermum Parkii (Shea) Butter, Aspalathus Linearis Leaf Extract, Lycium Barbarum (Goji) Fruit Extract, Punica Granatum (Pomegranate) Extract, Camellia Sinensis Leaf Extract, Vitis Vinifera (Grape) Seed Extract, Copaifera Officinalis Resin,Tocopherol, Oleic Acid, Palmitic Acid, Triolein, Bisabolol, Caprylhydroxamic Acid, Lecithin, Disodium Edta, Xanthan Gum, Linoleic Acid, Sodium Benzoate, Potassium Sorbate, Sodium Hydroxide, Citric Acid, Citrus Aurantium Peel Oil, Citrus Limon Peel Oil, Amyl Cinnamal, Terpineol, Geraniol, Limonene, Geranyl Acetate, Hydroxycitronellal, Linalyl Acetate, Linalool.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

RAPID REPAIR HEALING CREAM 
allantoin, dimethicone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65278-110
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	ALLANTOIN	0.9907 g  in 198.14 g
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	2.9721 g  in 198.14 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
STEARIC ACID (UNII: 4ELV7Z65AP)
CETEARYL ALCOHOL (UNII: 2DMT128M1S)
COPAIFERA OFFICINALIS RESIN (UNII: 1VH544O5AT)
OLEIC ACID (UNII: 2UMI9U37CP)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
XANTHAN GUM (UNII: TTV12P4NEE)
GERANIOL (UNII: L837108USY)
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
GERANYL ACETATE (UNII: 3W81YG7P9R)
TRIOLEIN (UNII: O05EC62663)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
ARGANIA SPINOSA KERNEL OIL (UNII: 4V59G5UW9X)
VITIS VINIFERA (GRAPE) SEED EXTRACT (UNII: RDS2V6DVY5)
PALMITIC ACID (UNII: 2V16EO95H1)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERYL STEARATE (UNII: 230OU9XXE4)
TOCOPHEROL (UNII: R0ZB2556P8)
TERPINEOL (UNII: R53Q4ZWC99)
LINOLEIC ACID (UNII: 9KJL21T0QJ)
GLYCERIN (UNII: PDC6A3C0OX)
OATMEAL (UNII: 8PI54V663Y)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
CITRUS AURANTIUM PEEL OIL (UNII: 9TLV70SV6I)
CITRUS LIMON (LEMON) PEEL OIL (UNII: I9GRO824LL)
CITRIC ACID (UNII: 2968PHW8QP)
AMYL CINNAMAL (UNII: WC51CA3418)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)
LYCIUM BARBARUM FRUIT (UNII: 930626MWDL)
BISABOLOL (UNII: 24WE03BX2T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SQUALANE (UNII: GW89575KF9)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALYL ACETATE (UNII: 5K47SSQ51G)
CERAMIDE NP (UNII: 4370DF050B)
SODIUM BENZOATE (UNII: OJ245FE5EU)
BENZYL ACETATE (UNII: 0ECG3V79ZJ)
LEONTOPODIUM NIVALE SUBSP. ALPINUM FLOWERING TOP (UNII: QQC1AK06RK)
PHYTOSTERYL MACADAMIATE (UNII: 233VSF903M)
BUTYROSPERMUM PARKII (SHEA) BUTTER (UNII: K49155WL9Y)
ASPALATHUS LINEARIS LEAF (UNII: H7UGK1GJCU)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
LINALOOL (UNII: D81QY6I88E)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
METHYL ANTHRANILATE (UNII: 981I0C1E5W)
PUNICA GRANATUM ROOT BARK (UNII: CLV24I3T1D)
CAMELLIA SINENSIS LEAF (UNII: W2ZU1RY8B0)

Product Characteristics
Color	white (White/offwhite)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65278-110-01	198.14 g in 1 TUBE; Type 0: Not a Combination Product	11/09/2011
2	NDC: 65278-110-02	198.14 g in 1 CARTON; Type 0: Not a Combination Product	11/09/2011
3	NDC: 65278-110-03	112.38 g in 1 TUBE; Type 0: Not a Combination Product	11/09/2011
4	NDC: 65278-110-04	112.38 g in 1 CARTON; Type 0: Not a Combination Product	11/09/2011
5	NDC: 65278-110-05	47.32 g in 1 TUBE; Type 0: Not a Combination Product	11/09/2011
6	NDC: 65278-110-06	47.32 g in 1 CARTON; Type 0: Not a Combination Product	11/09/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	11/09/2011

Labeler - June Jacobs Labs LLC (082439410)

Establishment
Name	Address	ID/FEI	Business Operations
June Jacobs Labs, LLC		122610681	manufacture(65278-110)