PERSONAL LUBRICANT (sambucus nigra flower calendula officinalis flower pine needle oil- pinus sylvestris salve

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

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Active ingredient:
SAMBUCUS NIGRA FLOWER (UNII: 07V4DX094T) (SAMBUCUS NIGRA FLOWER - UNII:07V4DX094T), CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) (CALENDULA OFFICINALIS FLOWER - UNII:P0M7O4Y7YD), PINE NEEDLE OIL (PINUS SYLVESTRIS) (UNII: 5EXL5H740Y) (PINE NEEDLE OIL (PINUS SYLVESTRIS) - UNII:5EXL5H740Y), BERBERIS VULGARIS FRUIT (UNII: 6XEF22AHC3) (BERBERIS VULGARIS FRUIT - UNII:6XEF22AHC3)
Available from:
PUREMEDY
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
PROPERTIES SKIN PROTECTANT SKIN PROTECTANT SKIN PROTECTANT FOR VAGINAL DRYNESS USES: TO RELIEVE SYMPTOMS ASSOCIATED WITH DRYNESS, MILD CANDIDA, AND MINOR SORES. NOT TO BE USED SOME LATEX CONDOMS.
Authorization status:
unapproved homeopathic
Authorization number:
52810-801-11

PERSONAL LUBRICANT- sambucus nigra flower calendula officinalis flower pine needle oil

(pinus sylvestris) salve

PUREMEDY

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.

----------

ACTIVE INGREDIENTS

ORG. SAMBUCUS NIGRA (2X) HPUS (ELDERBERRY)

ORG. CALENDULA OFFICINALIS (2X) HPUS) (MARIGOLD)

PINUS SILVESTRIS (2X) HPUS (PINE RESIN)

BERBERIS VULGARIS (3X) HPUS (BARBERRY)

PROPERTIES

SKIN PROTECTANT

SKIN PROTECTANT

SKIN PROTECTANT

FOR VAGINAL DRYNESS

USES: TO RELIEVE SYMPTOMS ASSOCIATED WITH DRYNESS, MILD CANDIDA, AND

MINOR SORES. NOT TO BE USED SOME LATEX CONDOMS.

DIRECTIONS: APPLY TO AFFECTED AREA AS NEEDED.

OTHER INGREDIENTS: ORGANIC OLIVE OIL, HIGH OLEIC SAFFLOWER OIL, ORGANIC

BEESWAX, CANADIAN FIR BALSAM

WARNING: TEST FOR ALLERGY BY RUBBING A SMALL AMOUNT ON SKIN FIRST. DO NOT

USE IF ALLERGIC TO OR HYPER-SENSITIVE TO ANY INGREDIENT IN THIS SALVE. IF

CONDITION PERSISTS OR WORSENS CONSULT YOUR HEALTH CARE PROVIDER. (* =

CERTIFIED ORGANIC INGREDIENTS)

KEEP OUT OF REACH OF CHILDREN.

CUSTOMER SERVICE 310-526-6108

STORE IN A COOL DRY PLACE OR REFRIGERATE

PERSONAL LUBRICANT

sambucus nigra flower calendula officinalis flower pine needle oil (pinus sylvestris) salve

Product Information

PUREMEDY

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:528 10 -8 0 1

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

SAMBUCUS NIGRA FLO WER (UNII: 0 7V4DX0 9 4T) (SAMBUCUS NIGRA FLOWER -

UNII:0 7V4DX0 9 4T)

SAMBUCUS NIGRA

FLOWER

2 [hp_X]

in 10 0 mL

CALENDULA O FFICINALIS FLO WER (UNII: P0 M7O4Y7YD) (CALENDULA

OFFICINALIS FLOWER - UNII:P0 M7O4Y7YD)

CALENDULA OFFICINALIS

FLOWER

2 [hp_X]

in 10 0 mL

PINE NEEDLE O IL ( PINUS SYLVESTRIS) (UNII: 5EXL5H740 Y) (PINE NEEDLE OIL

(PINUS SYLVESTRIS) - UNII:5EXL5H740 Y)

PINE NEEDLE OIL (PINUS

SYLVESTRIS)

2 [hp_X]

in 10 0 mL

BERBERIS VULGARIS FRUIT (UNII: 6 XEF22AHC3) (BERBERIS VULGARIS FRUIT -

UNII:6 XEF22AHC3)

BERBERIS VULGARIS

FRUIT

3 [hp_X]

in 10 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

O LIVE O IL (UNII: 6 UYK2W1W1E)

SAFFLO WER O IL (UNII: 6 5UEH26 2IS)

YELLO W WAX (UNII: 2ZA36 H0 S2V)

CANADA BALSAM (UNII: K30 4VI9 8 I3)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:528 10 -8 0 1-11

30 mL in 1 JAR; Type 0 : No t a Co mbinatio n Pro duct

10 /18 /20 12

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

unappro ved ho meo pathic

10 /18 /20 12

Labeler -

PUREMEDY (003552251)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

PUREMEDY

0 0 3552251

ma nufa c ture (528 10 -8 0 1)

Revised: 3/2020

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