PremarinVaginal — 0.625MG, Cream, carton of 1 × 30 g tube

PremarinVaginal — 0.625MG, Cream, carton of 1 × 30 g tube

PremarinVaginal (conjugated estrogens) is a cream for vaginal use. PREMARIN (conjugated estrogens) vaginal cream is a mixture of estrogens indicated for: • Treatment of Atrophic Vaginitis and Kraurosis Vulvae ( 1.1 ) • Treatment of Moderate to Severe Dyspareunia, a Symptom of Vulvar and Vaginal Atrophy, due to Menopause ( 1.2 ) 1.1 Treatment of Atrophic Vaginitis and Kraurosis Vulvae 1.2 Treatment of Moderate to Severe Dyspareunia, a Symptom of Vulvar and Vaginal Atrophy, due to Menopause

• Active ingredient or product type: ESTROGENS, CONJUGATED
• Strength/concentration: 0.625MG
• Dosage form and route: Cream, Vaginal
• Exact package presentation: carton of 1 × 30 g tube
• NDC/item number: 0046-0872-21
• Manufacturer: PFIZER PHARM
• Storage/handling: Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
• Status: Rx only

Important safety information: • Estrogens increase the risk of gallbladder disease ( 5.5 ) • Discontinue estrogen if severe hypercalcemia, loss of vision, severe hypertriglyceridemia or cholestatic jaundice occurs ( 5.6 , 5.7 , 5.10 , 5.11 ) • Monitor thyroid function in women on thyroid replacement therapy ( 5.12 , 5.21 ) 5.1 Risks from Systemic Absorption Systemic absorption occurs with the use of PREMARIN vaginal cream.

Refer to the current product labeling for complete indications, preparation or administration instructions, contraindications, warnings, precautions, and storage requirements.