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, Stearic acid, Glycerin, Caprylic/Capric Triglyceride, C12-15 Alkyl Benzoate, Glyceryl Stearate, Glyceryl Stearate SE, Cetearyl Alcohol, Fragrance/Parfum , Caprylyl Glycol, Squalane, Leontopodium Alpinum Flower/leaf Extract, Xanthan Gum, Linoleic Acid, Lecithin, Caprylhydroxamic Acid, Sodium Hydroxide, Phytosteryl Canola Glycerides, Disodium EDTA, Butyrospermum Parkii (Shea) Butter, Ceramide NP, Argania Spinosa Kernel Oil, Lycium Barbarum Fruit Extract, Punica Granatum Extract, Vitis Vinifera (Grape) Seed Extract, Aspalathus Linearis Leaf Extract, Oleic Acid, Palmitic Acid, Triolein, Tocopherol, Potassium Sorbate, Sodium Benzoate, Leuconostoc/Radish Root Ferment Filtrate, Bisabolol, Colloidal Oatmeal, Citric Acid,Camellia Sinensis Leaf Extract, Linalool, Amyl Cinnamal, Geraniol, Limonene , Hydroxycitronellal

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
LINALYL ACETATE (UNII: 5K47SSQ51G)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
TERPINEOL (UNII: R53Q4ZWC99)
ORANGE OIL (UNII: AKN3KSD11B)
GLYCERYL TRIOLEATE (UNII: O05EC62663)
SODIUM BENZOATE (UNII: OJ245FE5EU)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
WATER (UNII: 059QF0KO0R)
GERANIOL (UNII: L837108USY)
BENZYL ACETATE (UNII: 0ECG3V79ZJ)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
VITIS VINIFERA SEED (UNII: C34U15ICXA)
OATMEAL (UNII: 8PI54V663Y)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
TOCOPHEROL (UNII: R0ZB2556P8)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
STEARIC ACID (UNII: 4ELV7Z65AP)
LEMON OIL (UNII: I9GRO824LL)
ARGAN OIL (UNII: 4V59G5UW9X)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
EDETATE DISODIUM (UNII: 7FLD91C86K)
CERAMIDE NP (UNII: 4370DF050B)
LYCIUM BARBARUM FRUIT (UNII: 930626MWDL)
PUNICA GRANATUM ROOT BARK (UNII: CLV24I3T1D)
.ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
CITRUS RETICULATA LEAF OIL (UNII: 1515UE78IH)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
GLYCERIN (UNII: PDC6A3C0OX)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
OLEIC ACID (UNII: 2UMI9U37CP)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LEONTOPODIUM ALPINUM FLOWERING TOP (UNII: QQC1AK06RK)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SQUALANE (UNII: GW89575KF9)
XANTHAN GUM (UNII: TTV12P4NEE)
LINOLEIC ACID (UNII: 9KJL21T0QJ)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
PHYTOSTERYL MACADAMIATE (UNII: 233VSF903M)
SHEA BUTTER (UNII: K49155WL9Y)
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)
COPAIFERA OFFICINALIS RESIN (UNII: 1VH544O5AT)
ASPALATHUS LINEARIS LEAF (UNII: H7UGK1GJCU)
PALMITIC ACID (UNII: 2V16EO95H1)
PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)
METHYL ANTHRANILATE (UNII: 981I0C1E5W)
GERANYL ACETATE (UNII: 3W81YG7P9R)

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)