Label: VAMOUSSE LICE DEFENSE- pediculicide shampoo
- 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 June 28, 2023
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- Official Label (Printer Friendly)
- DRUG FACTS-Active Ingredients
- Purpose
- Uses
- Warnings
- Warnings
- Warnings
- Warnings
- Warnings
- Children's Warning
-
Directions
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?
- Additionl Label Content
-
VAMOUSSE LICE DEFENSE SHAMPOO 118 ML Bottle
SUPER LICE DEFENSE
NDC 72238-002-02
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
4 FL OZ (118 ml)
Drug Facts
Active Ingredients Purpose
Eucalyptus globulus 2X (HPUS) Pediculicide
Natrum muriaticum 2X (HPUS) Pediculicide
Uses: For daily defense against head lice infestations.
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.
Keep out of reach of children. If swallowed, get
medical help or contact a Poison Control Center right away.
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 Benzyl alcohol, Butyl lactate,
Cocamidopropyl betaine, Diazolidinyl urea, Fragrance, Isopropyl
myristate, Sodium chloride, Sodium lauryl s sulfate, Water
Questions? 1.855.373.7210 or www.VamousseLice.com
Call to report serious side effects
Vamousse, Alliance and associated devices are trade
marks of Alliance Pharmaceuticals Limited
Manufactured For:
Alliance Pharma Inc., Cary, NC 27511
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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 PLZ Corp 118914032 manufacture(72238-002) , label(72238-002) , pack(72238-002)