SUGAR BRANDS RESCUE PAIN RELIEF AND RECOVERY- lidocaine hydrochloride cream

United States - English - NLM (National Library of Medicine)

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Active ingredient:
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)
Available from:
Sugar Brands, LLC
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
- For the temporary relief of pain
Authorization status:
OTC monograph not final
Authorization number:
73313-075-04

SUGAR BRANDS RESCUE PAIN RELIEF AND RECOVERY- lidocaine hydrochloride cream

Sugar Brands, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they

comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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SUGAR BRANDS: Rescue Pain Relief & Recovery Cream

Drug Facts

Active Ingredient

Lidocaine HCl 4.00%

Purpose

Topical Analgesic

Uses

For the temporary relief of pain

Warnings

For external use only.

Avoid contact with eyes.

If symptoms persist for more than seven days, discontinue use and consult physician.

Keep out of reach of children.

If swallowed, consult physician.

Do not use

in large quantities, particularly over raw surfaces or blistered areas.

If pregnant or breast feeding,

contact physician prior to use.

Directions

Adults and children two-years of age or older:

Apply to affected area not more than three to four times daily.

Children under two-years of age: consult a physician.

Additional Information

Store at room temperature.

Other Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aesculus Hippocastanum (Horse Chestnut) Extract,

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Flower

Extract, Beta Alanine, Betaglucan, Boswellia Serrata Extract, Butyrospermum Parkii (Shea) Butter,

Cannabis Sativa (Hemp) Seed Oil, Cetyl Esters, Dimethicone, Ethoxydiglycol, Ethylhexylglycerin,

Ethyl Vanillin, Eucalyptus Globulus Oil, Glucosamine Sulfate, Glycerin, Glyceryl Stearate, Helianthus

Annuus (Sunflower) Oil, l-Arginine, l-Carnitine, l-Citruline, Magnesium Sulfate, Methyl Gluceth-20,

Methylsulfonylmethane (MSM), PEG-100 Stearate, Phenoxyethanol, Ribes Nigrum (Black Currant) Oil,

Salix Alba (Willow) Bark Extract, Steareth-20, Triethanolamine.

Package Labeling:

SUGAR BRANDS RESCUE PAIN RELIEF AND RECOVERY

lidocaine hydrochloride cream

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:73313-0 75

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

LIDO CAINE HYDRO CHLO RIDE (UNII: V130 0 7Z41A) (LIDOCAINE - UNII:9 8 PI20 0 9 8 7)

LIDOCAINE

40 mg in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

CARBO MER INTERPO LYMER TYPE A ( ALLYL SUCRO SE CRO SSLINKED) (UNII: 59 TL3WG5CO)

HO RSE CHESTNUT (UNII: 3C18 L6 RJAZ)

ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)

WATER (UNII: 0 59 QF0 KO0 R)

ARNICA MO NTANA FLO WER (UNII: OZ0 E5Y15PZ)

.BETA.-ALANINE (UNII: 11P2JDE17B)

INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)

SHEA BUTTER (UNII: K49 155WL9 Y)

CANNABIS SATIVA SEED O IL (UNII: 6 9 VJ1LPN1S)

CETYL ESTERS WAX (UNII: D0 72FFP9 GU)

DIMETHICO NE (UNII: 9 2RU3N3Y1O)

DIETHYLENE GLYCO L MO NO ETHYL ETHER (UNII: A1A1I8 X0 2B)

ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

ETHYL VANILLIN (UNII: YC9 ST449 YJ)

EUCALYPTUS O IL (UNII: 2R0 4ONI6 6 2)

GLUCO SAMINE SULFATE (UNII: 1FW7WLR731)

GLYCERIN (UNII: PDC6 A3C0 OX)

GLYCERYL MO NO STEARATE (UNII: 230 OU9 XXE4)

HELIANTHUS ANNUUS FLO WERING TO P (UNII: BKJ0 J3D1BP)

ARGININE (UNII: 9 4ZLA3W45F)

LEVO CARNITINE (UNII: 0 G38 9 FZZ9 M)

CITRULLINE (UNII: 29 VT0 7BGDA)

MAGNESIUM SULFATE, UNSPECIFIED FO RM (UNII: DE0 8 0 37SAB)

METHYL GLUCETH-2 0 (UNII: J3QD0 LD11P)

DIMETHYL SULFO NE (UNII: 9 H4PO4Z4FT)

PEG-10 0 STEARATE (UNII: YD0 1N19 9 9 R)

PHENO XYETHANO L (UNII: HIE49 2ZZ3T)

BLACK CURRANT (UNII: 9 755T40 D11)

SALIX ALBA BARK (UNII: 20 5MXS71H7)

STEARETH-2 0 (UNII: L0 Q8 IK9 E0 8 )

TRO LAMINE (UNII: 9 O3K9 3S3TK)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:73313-0 75-0 4

118 mL in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

0 8 /20 /20 19

Sugar Brands, LLC

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt348

0 8 /20 /20 19

Labeler -

Sugar Brands, LLC (050377177)

Revised: 8/2019

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