Sebrx Topical Analgesic

Dosage form: gel
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 2g in 100mL
Labeler: Goodier Cosmetics LP
NDC Code: 10477-3410

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.

Sebrx Retail 2 fl oz Topical Analgesic

    sebRx

    Oil Control Gel
    Topical Analgesic

    2 fl oz / 60 ml

    Active Ingredient
    Diphenhydramine HCl 2%
    Purpose
    External Analgesic

    For the temporary relief
    of pain and itching associated
    with minor skin irritations.

    Uses • For the temporary relief
    of pain and itching associated
    with minor skin irritations.

    Warnings
    When using this product

    • Avoid contact with eyes.

    Stop use and ask a physician if
    • Condition worsens.
    • Symptoms persist for more
    than 7 days.
    • Symptoms clear up and
    occur again within a few days.

    For external use only.

    Keep this and all drugs out of
    reach of children. If swallowed,
    get medical help or contact a
    Poison Control Center right away.

    Directions • Shake well
    before use. Adults/children 2
    years of age and older:

    • Dispense 4 pumps of
    product into palm of hand.
    • Apply to affected area
    2 times daily.
    Children under 2 years of age:
    • Consult a physician.

    Other Information
    Store at 68-77°F (20-25°C)

    Inactive Ingredients
    Water (Aqua), SD Alcohol 40
    (Alcohol Denat.), Ethoxydiglycol,
    Sodium Lactate, Cucurbita Pepo
    (Pumpkin) Seed Extract,
    Zingiber Officinalis (Ginger)
    Root Extract, Cinnamomum
    Cassia Bark Extract, Poterium
    Officinale (Burnet) Root Extract,
    Hydroxyethylcellulose, Butylene
    Glycol, Phenoxyethanol, Salicylic
    Acid, Citric Acid


    Dist. By Revision, Inc
    Dallas, TX 75247 Made In USA

SEBRX TOPICAL ANALGESIC 
diphenhydramine hydrochloride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10477-3410
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
DIETHYLENE GLYCOL MONOETHYL ETHER 
SODIUM LACTATE 
PUMPKIN SEED 
GINGER 
CHINESE CINNAMON 
SANGUISORBA OFFICINALIS ROOT 
HYDROXYETHYL CELLULOSE (2000 MPA.S FOR 1% AQUEOUS SOLUTION) 
BUTYLENE GLYCOL 
PHENOXYETHANOL 
SALICYLIC ACID 
ANHYDROUS CITRIC ACID 
Packaging
#Item CodePackage Description
1NDC:10477-3410-160 mL in 1 BOTTLE, PLASTIC
2NDC:10477-3410-21 BOTTLE, PLASTIC (BOTTLE) in 1 CARTON
260 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34802/01/2008
Labeler - Goodier Cosmetics LP (007317209)
Registrant - Goodier Cosmetics LP (007317209)
Establishment
NameAddressID/FEIOperations
Goodier Cosmetics LP007317209manufacture

Revised: 12/2011
 
Goodier Cosmetics LP

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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