Label: VAMOUSSE LICE DEFENSE- pediculicide shampoo
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Contains inactivated NDC Code(s)
NDC Code(s): 72238-002-02 - Packager: Alliance Pharma Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.
Drug Label Information
Updated December 30, 2020
If you are a consumer or patient please visit this version.
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- Drug Facts
- Active Ingredients
- Purpose
- Uses:
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Warnings
For external use only.
Do not use • near eyes • inside nose, mouth, or vagina • on eyebrows or eyelashes. See a doctor if lice are present in these areas. Do not use if you have ever had an allergic reaction to this product or any of its ingredients.
When using this product
• Do not use in or near the eyes. Close eyes while applying.
• Do not permit contact with mucous membranes, such as inside the nose, as irritation or stinging may occur.
Stop use and ask a doctor • if eye irritation occurs • skin or scalp irritation or infection occurs.
If pregnant or breast-feeding, Ask a health professional before use.
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Directions:
Adults and children 2 years and older:
• Apply a generous amount of shampoo to wet hair, work into a lather and massage into scalp. Leave shampoo in hair for at least 3 minutes. Rinse.
• Use daily for at least 10 - 14 days following treatment, during risk of re-infestation.
• For an active head lice infestation, use Vamousse Lice Treatment before using this shampoo.
Children under 2 years: ask a doctor.
Product may be used as often as needed.
- Inactive Ingredients:
- Questions?
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SPL UNCLASSIFIED SECTION
SUPER LICE DEFENSE
DAILY DEFENSE AGAINST LICE
LICE DEFENSE
VAMOUSSE®
HOMEOPATHIC
GENTLE SHAMPOO
• Kills Lice*
for treatment follow-up
• Safe, Non-Toxic
when used as directed
• Pesticide-Free
*as shown in lab studies
Vamousse, Alliance and associated devices are trademarks of Alliance Pharmaceuticals Limited
Manufactured For: ALLIANCE
Alliance Pharma Inc., Cary, NC 27511
- Packaging
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INGREDIENTS AND APPEARANCE
VAMOUSSE LICE DEFENSE
pediculicide shampooProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72238-002 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6) (EUCALYPTUS GLOBULUS LEAF - UNII:S546YLW6E6) EUCALYPTUS GLOBULUS LEAF 2 [hp_X] in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE 2 [hp_X] in 1 mL Inactive Ingredients Ingredient Name Strength MENTHA ARVENSIS FLOWER OIL (UNII: Q129Z1W6Y2) EUCALYPTUS OIL (UNII: 2R04ONI662) PEPPERMINT (UNII: V95R5KMY2B) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) LINALOOL, (+/-)- (UNII: D81QY6I88E) MENTHYL ACETATE, (-)- (UNII: W8C5F4H1OA) OCTYL ACETATE (UNII: X0FN2J413S) PEPPERMINT OIL (UNII: AV092KU4JH) SODIUM LAURYL SULFATE (UNII: 368GB5141J) PENNYROYAL OIL (UNII: AK85U7Y3MV) CARVONE, (-)- (UNII: 5TO7X34D3D) ORANGE OIL (UNII: AKN3KSD11B) LIMONENE, (+)- (UNII: GFD7C86Q1W) MENTHONE, (+/-)- (UNII: 9NH5J4V8FN) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) CITRAL (UNII: T7EU0O9VPP) LEMON OIL (UNII: I9GRO824LL) GERANYL ACETATE (UNII: 3W81YG7P9R) SPEARMINT OIL (UNII: C3M81465G5) LEVOMENTHOL (UNII: BZ1R15MTK7) WATER (UNII: 059QF0KO0R) DECANAL (UNII: 31Z90Q7KQJ) CARYOPHYLLENE (UNII: BHW853AU9H) DIPROPYLENE GLYCOL (UNII: E107L85C40) LINALYL ACETATE, (+)- (UNII: 3ID3M89AV9) BERGAMOT OIL (UNII: 39W1PKE3JI) BUTYL LACTATE (UNII: 0UI63W814U) BENZYL ALCOHOL (UNII: LKG8494WBH) .ALPHA.-TERPINEOL (UNII: 21334LVV8W) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72238-002-02 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/21/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 08/21/2019 Labeler - Alliance Pharma Inc. (081138954) Establishment Name Address ID/FEI Business Operations Pharmasol Corporation 065144289 manufacture(72238-002) , label(72238-002) , pack(72238-002)
